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1.  Artificial Discs for Lumbar and Cervical Degenerative Disc Disease –Update 
Executive Summary
To assess the safety and efficacy of artificial disc replacement (ADR) technology for degenerative disc disease (DDD).
Clinical Need
Degenerative disc disease is the term used to describe the deterioration of 1 or more intervertebral discs of the spine. The prevalence of DDD is roughly described in proportion to age such that 40% of people aged 40 years have DDD, increasing to 80% among those aged 80 years or older. Low back pain is a common symptom of lumbar DDD; neck and arm pain are common symptoms of cervical DDD. Nonsurgical treatments can be used to relieve pain and minimize disability associated with DDD. However, it is estimated that about 10% to 20% of people with lumbar DDD and up to 30% with cervical DDD will be unresponsive to nonsurgical treatments. In these cases, surgical treatment is considered. Spinal fusion (arthrodesis) is the process of fusing or joining 2 bones and is considered the surgical gold standard for DDD.
Artificial disc replacement is the replacement of the degenerated intervertebral disc with an artificial disc in people with DDD of the lumbar or cervical spine that has been unresponsive to nonsurgical treatments for at least 6 months. Unlike spinal fusion, ADR preserves movement of the spine, which is thought to reduce or prevent the development of adjacent segment degeneration. Additionally, a bone graft is not required for ADR, and this alleviates complications, including bone graft donor site pain and pseudoarthrosis. It is estimated that about 5% of patients who require surgery for DDD will be candidates for ADR.
Review Strategy
The Medical Advisory Secretariat conducted a computerized search of the literature published between 2003 and September 2005 to answer the following questions:
What is the effectiveness of ADR in people with DDD of the lumbar or cervical regions of the spine compared with spinal fusion surgery?
Does an artificial disc reduce the incidence of adjacent segment degeneration (ASD) compared with spinal fusion?
What is the rate of major complications (device failure, reoperation) with artificial discs compared with surgical spinal fusion?
One reviewer evaluated the internal validity of the primary studies using the criteria outlined in the Cochrane Musculoskeletal Injuries Group Quality Assessment Tool. The quality of concealment allocation was rated as: A, clearly yes; B, unclear; or C, clearly no. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to evaluate the overall quality of the body of evidence (defined as 1 or more studies) supporting the research questions explored in this systematic review. A random effects model meta-analysis was conducted when data were available from 2 or more randomized controlled trials (RCTs) and when there was no statistical and or clinical heterogeneity among studies. Bayesian analyses were undertaken to do the following:
Examine the influence of missing data on clinical success rates;
Compute the probability that artificial discs were superior to spinal fusion (on the basis of clinical success rates);
Examine whether the results were sensitive to the choice of noninferiority margin.
Summary of Findings
The literature search yielded 140 citations. Of these, 1 Cochrane systematic review, 1 RCT, and 10 case series were included in this review. Unpublished data from an RCT reported in the grey literature were obtained from the manufacturer of the device. The search also yielded 8 health technology assessments evaluating ADR that are also included in this review.
Six of the 8 health technology assessments concluded that there is insufficient evidence to support the use of either lumbar or cervical ADR. The results of the remaining 2 assessments (one each for lumbar and cervical ADR) led to a National Institute for Clinical Excellence guidance document supporting the safety and effectiveness of lumbar and cervical ADR with the proviso that an ongoing audit of all clinical outcomes be undertaken owing to a lack of long-term outcome data from clinical trials.
Regarding lumbar ADR, data were available from 2 noninferiority RCTs to complete a meta-analysis. The following clinical, health systems, and adverse event outcome measures were synthesized: primary outcome of clinical success, Oswestry Disability Index (ODI) scores, pain VAS scores, patient satisfaction, duration of surgery, amount of blood loss, length of hospital stay, rate of device failure, and rate of reoperation.
The meta-analysis of overall clinical success supported the noninferiority of lumbar ADR compared with spinal fusion at 24-month follow-up. Of the remaining clinical outcome measures (ODI, pain VAS scores, SF-36 scores [mental and physical components], patient satisfaction, and return to work status), only patient satisfaction and scores on the physical component scale of the SF-36 questionnaire were significantly improved in favour of lumbar ADR compared with spinal fusion at 24 months follow-up. Blood loss and surgical time showed statistical heterogeneity; therefore, meta-analysis results are not interpretable. Length of hospital stay was significantly shorter in patients receiving the ADR compared with controls. Neither the number of device failures nor the number of neurological complications at 24 months was statistically significantly different between the ADR and fusion treatment groups. However, there was a trend towards fewer neurological complications at 24 months in the ADR treatment group compared with the spinal fusion treatment group.
Results of the Bayesian analyses indicated that the influence of missing data on the outcome measure of clinical success was minimal. The Bayesian model indicated that the probability for ADR being better than spinal fusion was 79%. The probability of ADR being noninferior to spinal fusion using a -10% noninferiority bound was 92%, and using a -15% noninferiority bound was 94%. The probability of artificial discs being superior to spinal fusion in a future trial was 73%.
Six case series were reviewed, mainly to characterize the rate of major complications for lumbar ADR. The Medical Advisory Secretariat defined a major complication as any reoperation; device failure necessitating a revision, removal or reoperation; or life-threatening event. The rates of major complications ranged from 0% to 13% per device implanted. Only 1 study reported the rate of ASD, which was detected in 2 (2%) of the 100 people 11 years after surgery.
There were no RCT data available for cervical ADR; therefore, data from 4 case series were reviewed for evidence of effectiveness and safety. Because data were sparse, the effectiveness of cervical ADR compared with spinal fusion cannot be determined at this time.
The rate of major complications was assessed up to 2 years after surgery. It was found to range from 0% to 8.1% per device implanted. The rate of ASD is not reported in the clinical trial literature.
The total cost of a lumbar ADR procedure is $15,371 (Cdn; including costs related to the device, physician, and procedure). The total cost of a lumbar fusion surgery procedure is $11,311 (Cdn; including physicians’ and procedural costs).
Lumbar Artificial Disc Replacement
Since the 2004 Medical Advisory Secretariat health technology policy assessment, data from 2 RCTs and 6 case series assessing the effectiveness and adverse events profile of lumbar ADR to treat DDD has become available. The GRADE quality of this evidence is moderate for effectiveness and for short-term (2-year follow-up) complications; it is very low for ASD.
The effectiveness of lumbar ADR is not inferior to that of spinal fusion for the treatment of lumbar DDD. The rates for device failure and neurological complications 2 years after surgery did not differ between ADR and fusion patients. Based on a Bayesian meta-analysis, lumbar ADR is 79% superior to lumbar spinal fusion.
The rate of major complications after lumbar ADR is between 0% and 13% per device implanted. The rate of ASD in 1 case series was 2% over an 11-year follow-up period.
Outcome data for lumbar ADR beyond a 2-year follow-up are not yet available.
Cervical Artificial Disc Replacement
Since the 2004 Medical Advisory Secretariat health technology policy assessment, 4 case series have been added to the body of evidence assessing the effectiveness and adverse events profile of cervical ADR to treat DDD. The GRADE quality of this evidence is very low for effectiveness as well as for the adverse events profile. Sparse outcome data are available.
Because data are sparse, the effectiveness of cervical ADR compared with spinal fusion cannot be determined at this time.
The rate of major complications was assessed up to 2 years after surgery; it ranged from 0% to 8.1% per device implanted. The rate of ASD is not reported in the clinical trial literature.
PMCID: PMC3379529  PMID: 23074480
2.  Minimally invasive 360° instrumented lumbar fusion 
European Spine Journal  2000;9(Suppl 1):S051-S056.
A retrospective preliminary study was undertaken of combined minimally invasive instrumented lumbar fusion utilizing the BERG (balloon-assisted endoscopic retroperitoneal gasless) approach ¶anteriorly, and a posterior small-incision approach with translaminar screw fixation and posterolateral ¶fusion. The study aimed to quantify the clinical and radiological results using this combined technique. The traditional minimally invasive approach to the anterior lumbar spine involves gas insufflation and provides reliable access only to L5-S1 and in some cases L4-5. A gas-mediated approach yields many technical drawbacks to performing spinal surgery. A minimally invasive posterior approach involving suprafascial pedicle screw instrumentation has been developed, but without widespread use. Translaminar facet fixation may be a viable alternative to transpedicular fixation in a 360° instrumented fusion model. Past studies have shown open 360° instrumented lumbar fusion yields high arthrodesis rates. The study examined the cases of 46 patients who underwent successful 360° instrumented lumbar fusion using a combined minimally invasive approach. Anterior lumbar interbody fusion (ALIF) at one or two levels was performed through the BERG approach; a gasless retroperitoneal approach to the lumbar spine allowing the use ¶of standard anterior instrumentation. Posteriorly, all patients underwent successful decompression, translaminar fixation, and posterolateral fusion at one or two levels through ¶one small (2.5–5.0 cm) incision. Results showed mean hospital stay of 2.02 days; mean combined blood loss was 255 cc; and mean pain relief was 56%, with 75.5% of patients reporting good, excellent, or total pain relief. Forty-two of 46 patients (93.2%) achieved a solid fusion ¶24 months after surgery. A total of 47% of all patients working prior to surgery returned to work following surgery. The study showed that minimally invasive 360° instrumented lumbar fusion, when performed utilizing these approaches, yields a high rate of solid arthrodesis (93.3%), good pain relief, short hospital stays, low blood losses, accelerated rehabilitation, and a quick return to the workforce. The BERG approach offers technical advantages over the traditional gas-mediated laparoscopic approach to the anterior lumbar spine.
PMCID: PMC3611432  PMID: 10766058
Key words Minimally Invasive; 360° lumbar fusion; Combined ¶anteroposterior; Gasless endoscopy; Translaminar fixation
3.  Comparing Miniopen and Minimally Invasive Transforaminal Interbody Fusion in Single-Level Lumbar Degeneration 
BioMed Research International  2015;2015:168384.
Degenerative diseases of the lumbar spine, which are common among elderly people, cause back pain and radicular symptoms and lead to a poor quality of life. Lumbar spinal fusion is a standardized and widely accepted surgical procedure used for treating degenerative lumbar diseases; however, the classical posterior approach used in this procedure is recognized to cause vascular and neurologic damage of the lumbar muscles. Various studies have suggested that using the minimally invasive transforaminal interbody fusion (TLIF) technique provides long-term clinical outcomes comparable to those of open TLIF approaches in selected patients. In this study, we compared the perioperative and short-term advantages of miniopen, MI, and open TLIF. Compared with open TLIF, MI-TLIF and miniopen TLIF were associated with less blood loss, shorter hospital stays, and longer operative times; however, following the use of these procedures, no difference in quality of life was measured at 6 months or 1 year. Whether miniopen TLIF or MI-TLIF can replace traditional TLIF as the surgery of choice for treating degenerative lumbar deformity remains unclear, and additional studies are required for validating the safety and efficiency of these procedures.
PMCID: PMC4299488  PMID: 25629037
4.  Minimally invasive surgical procedures for the treatment of lumbar disc herniation 
In up to 30% of patients undergoing lumbar disc surgery for herniated or protruded discs outcomes are judged unfavourable. Over the last decades this problem has stimulated the development of a number of minimally-invasive operative procedures. The aim is to relieve pressure from compromised nerve roots by mechanically removing, dissolving or evaporating disc material while leaving bony structures and surrounding tissues as intact as possible. In Germany, there is hardly any utilisation data for these new procedures – data files from the statutory health insurances demonstrate that about 5% of all lumbar disc surgeries are performed using minimally-invasive techniques. Their real proportion is thought to be much higher because many procedures are offered by private hospitals and surgeries and are paid by private health insurers or patients themselves. So far no comprehensive assessment comparing efficacy, safety, effectiveness and cost-effectiveness of minimally-invasive lumbar disc surgery to standard procedures (microdiscectomy, open discectomy) which could serve as a basis for coverage decisions, has been published in Germany.
Against this background the aim of the following assessment is:
Based on published scientific literature assess safety, efficacy and effectiveness of minimally-invasive lumbar disc surgery compared to standard procedures. To identify and critically appraise studies comparing costs and cost-effectiveness of minimally-invasive procedures to that of standard procedures. If necessary identify research and evaluation needs and point out regulative needs within the German health care system. The assessment focusses on procedures that are used in elective lumbar disc surgery as alternative treatment options to microdiscectomy or open discectomy. Chemonucleolysis, percutaneous manual discectomy, automated percutaneous lumbar discectomy, laserdiscectomy and endoscopic procedures accessing the disc by a posterolateral or posterior approach are included.
In order to assess safety, efficacy and effectiveness of minimally-invasive procedures as well as their economic implications systematic reviews of the literature are performed. A comprehensive search strategy is composed to search 23 electronic databases, among them MEDLINE, EMBASE and the Cochrane Library. Methodological quality of systematic reviews, HTA reports and primary research is assessed using checklists of the German Scientific Working Group for Health Technology Assessment. Quality and transparency of cost analyses are documented using the quality and transparency catalogues of the working group. Study results are summarised in a qualitative manner. Due to the limited number and the low methodological quality of the studies it is not possible to conduct metaanalyses. In addition to the results of controlled trials results of recent case series are introduced and discussed.
The evidence-base to assess safety, efficacy and effectiveness of minimally-invasive lumbar disc surgery procedures is rather limited:
Percutaneous manual discectomy: Six case series (four after 1998)Automated percutaneous lumbar discectomy: Two RCT (one discontinued), twelve case series (one after 1998)Chemonucleolysis: Five RCT, five non-randomised controlled trials, eleven case seriesPercutaneous laserdiscectomy: One non-randomised controlled trial, 13 case series (eight after 1998)Endoscopic procedures: Three RCT, 21 case series (17 after 1998)
There are two economic analyses each retrieved for chemonucleolysis and automated percutaneous discectomy as well as one cost-minimisation analysis comparing costs of an endoscopic procedure to costs for open discectomy.
Among all minimally-invasive procedures chemonucleolysis is the only of which efficacy may be judged on the basis of results from high quality randomised controlled trials (RCT). Study results suggest that the procedure maybe (cost)effectively used as an intermediate therapeutical option between conservative and operative management of small lumbar disc herniations or protrusions causing sciatica. Two RCT comparing transforaminal endoscopic procedures with microdiscectomy in patients with sciatica and small non-sequestered disc herniations show comparable short and medium term overall success rates. Concerning speed of recovery and return to work a trend towards more favourable results for the endoscopic procedures is noted. It is doubtful though, whether these results from the eleven and five years old studies are still valid for the more advanced procedures used today. The only RCT comparing the results of automated percutaneous lumbar discectomy to those of microdiscectomy showed clearly superior results of microdiscectomy. Furthermore, success rates of automated percutaneous lumbar discectomy reported in the RCT (29%) differ extremely from success rates reported in case series (between 56% and 92%).
The literature search retrieves no controlled trials to assess efficacy and/or effectiveness of laser-discectomy, percutaneous manual discectomy or endoscopic procedures using a posterior approach in comparison to the standard procedures. Results from recent case series permit no assessment of efficacy, especially not in comparison to standard procedures. Due to highly selected patients, modi-fications of operative procedures, highly specialised surgical units and poorly standardised outcome assessment results of case series are highly variable, their generalisability is low.
The results of the five economical analyses are, due to conceptual and methodological problems, of no value for decision-making in the context of the German health care system.
Aside from low methodological study quality three conceptual problems complicate the interpretation of results.
Continuous further development of technologies leads to a diversity of procedures in use which prohibits generalisation of study results. However, diversity is noted not only for minimally-invasive procedures but also for the standard techniques against which the new developments are to be compared. The second problem refers to the heterogeneity of study populations. For most studies one common inclusion criterion was "persisting sciatica after a course of conservative treatment of variable duration". Differences among study populations are noted concerning results of imaging studies. Even within every group of minimally-invasive procedure, studies define their own in- and exclusion criteria which differ concerning degree of dislocation and sequestration of disc material. There is the non-standardised assessment of outcomes which are performed postoperatively after variable periods of time. Most studies report results in a dichotomous way as success or failure while the classification of a result is performed using a variety of different assessment instruments or procedures. Very often the global subjective judgement of results by patients or surgeons is reported. There are no scientific discussions whether these judgements are generalisable or comparable, especially among studies that are conducted under differing socio-cultural conditions. Taking into account the weak evidence-base for efficacy and effectiveness of minimally-invasive procedures it is not surprising that so far there are no dependable economic analyses.
Conclusions that can be drawn from the results of the present assessment refer in detail to the specified minimally-invasive procedures of lumbar disc surgery but they may also be considered exemplary for other fields where optimisation of results is attempted by technological development and widening of indications (e.g. total hip replacement).
Compared to standard technologies (open discectomy, microdiscectomy) and with the exception of chemonucleolysis, the developmental status of all other minimally-invasive procedures assessed must be termed experimental. To date there is no dependable evidence-base to recommend their use in routine clinical practice. To create such a dependable evidence-base further research in two directions is needed: a) The studies need to include adequate patient populations, use realistic controls (e.g. standard operative procedures or continued conservative care) and use standardised measurements of meaningful outcomes after adequate periods of time. b) Studies that are able to report effectiveness of the procedures under everyday practice conditions and furthermore have the potential to detect rare adverse effects are needed. In Sweden this type of data is yielded by national quality registries. On the one hand their data are used for quality improvement measures and on the other hand they allow comprehensive scientific evaluations. Since the year of 2000 a continuous rise in utilisation of minimally-invasive lumbar disc surgery is observed among statutory health insurers. Examples from other areas of innovative surgical technologies (e.g. robot assisted total hip replacement) indicate that the rise will probably continue - especially because there are no legal barriers to hinder introduction of innovative treatments into routine hospital care. Upon request by payers or providers the "Gemeinsamer Bundesausschuss" may assess a treatments benefit, its necessity and cost-effectiveness as a prerequisite for coverage by the statutory health insurance. In the case of minimally-invasive disc surgery it would be advisable to examine the legal framework for covering procedures only if they are provided under evaluation conditions. While in Germany coverage under evaluation conditions is established practice in ambulatory health care only (“Modellvorhaben") examples from other European countries (Great Britain, Switzerland) demonstrate that it is also feasible for hospital based interventions. In order to assure patient protection and at the same time not hinder the further development of new and promising technologies provision under evaluation conditions could also be realised in the private health care market - although in this sector coverage is not by law linked to benefit, necessity and cost-effectiveness of an intervention.
PMCID: PMC3011322  PMID: 21289928
5.  Clinical outcomes of minimally invasive versus open approach for one-level transforaminal lumbar interbody fusion at the 3- to 4-year follow-up 
European Spine Journal  2013;22(12):2857-2863.
Supporters of minimally invasive approaches for transforaminal lumbar interbody fusion (TLIF) have reported short-term advantages associated with a reduced soft tissue trauma. Nevertheless, mid- and long-term outcomes and specifically those involving physical activities have not been adequately studied. The aim of this study was to compare the clinical outcomes of mini-open versus classic open surgery for one-level TLIF, with an individualized evaluation of the variables used for the clinical assessment.
A prospective cohort study was conducted of 41 individuals with degenerative disc disease who underwent a one-level TLIF from January 2007 to June 2008. Patients were randomized into two groups depending on the type of surgery performed: classic open (CL-TLIF) group and mini-open approach (MO-TLIF) group. The visual analog scale (VAS), North American Spine Society (NASS) Low Back Pain Outcome instrument, Oswestry Disability Index (ODI) and the Short Form 36 Health Survey (SF-36) were used for clinical assessment in a minimum 3-year follow-up (36–54 months).
Patients of the MO-TLIF group presented lower rates of lumbar (p = 0.194) and sciatic pain (p = 0.427) and performed better in daily life activities, especially in those requiring mild efforts: lifting slight weights (p = 0.081), standing (p = 0.097), carrying groceries (p = 0.033), walking (p = 0.069) and dressing (p = 0.074). Nevertheless, the global scores of the clinical questionnaires showed no statistical differences between the CL-TLIF and the MO-TLIF groups.
Despite an improved functional status of MO-TLIF patients in the short term, the clinical outcomes of mini-open TLIF at the 3- to 4-year follow-up showed no clinically relevant differences to those obtained with open TLIF.
PMCID: PMC3843777  PMID: 23764765
Minimally invasive; TLIF; Lumbar fusion; Degenerative disc disease; Prospective
6.  Lumbar degenerative spinal deformity: Surgical options of PLIF, TLIF and MI-TLIF 
Indian Journal of Orthopaedics  2010;44(2):159-162.
Degenerative disease of the lumbar spine is common in ageing populations. It causes disturbing back pain, radicular symptoms and lowers the quality of life. We will focus our discussion on the surgical options of posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) and minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) for lumbar degenerative spinal deformities, which include symptomatic spondylolisthesis and degenerative scoliosis. Through a description of each procedure, we hope to illustrate the potential benefits of TLIF over PLIF. In a retrospective study of 53 ALIF/PLIF patients and 111 TLIF patients we found reduced risk of vessel and nerve injury in TLIF patients due to less exposure of these structures, shortened operative time and reduced intra-operative bleeding. These advantages could be translated to shortened hospital stay, faster recovery period and earlier return to work. The disadvantages of TLIF such as incomplete intervertebral disc and vertebral end-plate removal and potential occult injury to exiting nerve root when under experienced hands are rare. Hence TLIF remains the mainstay of treatment in degenerative deformities of the lumbar spine. However, TLIF being a unilateral transforaminal approach, is unable to decompress the opposite nerve root. This may require contralateral laminotomy, which is a fairly simple procedure. The use of minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) to treat degenerative lumbar spinal deformity is still in its early stages. Although the initial results appear promising, it remains a difficult operative procedure to master with a steep learning curve. In a recent study comparing 29 MI-TLIF patients and 29 open TLIF, MI-TLIF was associated with longer operative time, less blood loss, shorter hospital stay, with no difference in SF-36 scores at six months and two years. Whether it can replace traditional TLIF as the surgery of choice for degenerative lumbar deformity remains unknown and more studies are required to validate the safety and efficiency.
PMCID: PMC2856390  PMID: 20419002
Degenerative spine; lumbar spine fusion; minimally invasive transforaminal fusion
7.  Mini-open anterior spine surgery for anterior lumbar diseases 
European Spine Journal  2008;17(5):691-697.
Minimally invasive surgeries including endoscopic surgery and mini-open surgery are current trend of spine surgery, and its main advantages are shorter recovery time and cosmetic benefits, etc. However, mini-open surgery is easier and less technique demanding than endoscopic surgery. Besides, anterior spinal fusion is better than posterior spinal fusion while considering the physiological loading, back muscle function, etc. Therefore, we aimed to introduce the modified “mini-open anterior spine surgery” (MOASS) and to evaluate the feasibility, effectiveness and safety in the treatment of various anterior lumbar diseases with this technique. A total of 61 consecutive patients (46 female, 15 male; mean age 58.2 years) from 1997 to 2004 were included in this study, with an average follow-up of 24–52 (mean 43) months. The disease entities included vertebral fracture (20), failed back surgery (13), segmental instability or spondylolisthesis (10), infection (8), herniated disc (5), undetermined lesion for biopsy (4), and hemivertebra (1). Lesions involved 13 cases at T12–L1, 18 at L1–L2, 18 at L2–L3, 22 at L3–L4 and 11 at L4–L5 levels. All patients received a single stage anterior-only procedure for their anterior lumbar disease. We used the subjective clinical results, Oswestry disability index, fusion rate, and complications to evaluate our clinical outcome. Most patients (91.8%) were subjectively satisfied with the surgery and had good-to-excellent outcomes. Mean operation time was 85 (62–124) minutes, and mean blood loss was 136 (minimal-250) ml in the past 6 years. Hospital stay ranged from 4–26 (mean 10.6) days. Nearly all cases had improved back pain (87%), physical function (90%) and life quality (85%). Most cases (95%) achieved solid or probable solid bony fusion. There were no major complications. Therefore, MOASS is feasible, effective and safe for patients with various anterior lumbar diseases.
PMCID: PMC2367411  PMID: 18327620
Mini-open anterior spine surgery; Mini-open; Anterior lumbar interbody fusion; Techniques; Lumbar fusion; ALIF
8.  A minimally invasive posterior lumbar interbody fusion for degenerative lumbar spine instabilities 
European Spine Journal  2011;20(Suppl 1):41-45.
Percutaneous techniques may be helpful to reduce approach-related morbidity of conventional open surgery. The aim of the study was to evaluate the feasibility and safety of mini-open posterior lumbar interbody fusion for instabilities and degenerative disc diseases. From May 2005 until October 2008, 20 patients affected by monosegmental instability and disc herniation underwent mini-open lumbar interbody fusion combined with percutaneous pedicle screw fixation of the lumbar spine. Clinical outcome was assessed using the Visual Analog Scale, Oswestry Disability Index, and Short Form Health Survey-36. The mean follow-up was 24 months. The mean estimated blood loss was 126 ml; the mean length of stay was 5.3 days; the mean operative time was 171 min. At 24-month follow-up, the mean VAS score was 2.1, mean ODI was 27.1%, and mean SF-36 was 85.2%. 80 screws were implanted in 20 patients. 74 screws showed very good position, 5 screws acceptable, and 1 screw unacceptable. A solid fusion was achieved in 17 patients (85%). In our opinion, mini-open TLIF is a valid and safe treatment of lumbar instability and degenerative disc diseases in order to obtain faster return to daily activities.
PMCID: PMC3087039  PMID: 21445617
Percutaneous pedicle screw; Minimally invasive fusion; Disc herniation
9.  A 10-year follow-up of transpedicular screw fixation and intervertebral autogenous posterior iliac crest bone graft or intervertebral B-Twin system in failed back surgery syndrome 
Asian Journal of Neurosurgery  2015;10(2):75-82.
The spine surgeons have been combining anterior and posterolateral fusion (circumferential fusion) as the final solution to treat spinal disorders and many have been using it to treat failed back surgery syndrome (FBSS). In present study, we analyzed and compared the clinical and radiological outcomes in patients with transpedicular screw fixation and intervertebral autogenous posterior iliac crest bone graft or in patients with transpedicular screw fixation and intervertebral B-Twin system for FBSS with a follow-up period of 10 years after the surgery.
Materials and Methods:
This study was a retrospective case study performed on 55 patients with FBSS. Clinical and radiological changes were compared between the two groups of patients on the basis of improvement of back pain, radicular pain, and work capacity. Outcome was measured in terms of Oswestry Low Back Pain Disability Index, and the changes in pain and function were documented every year from before surgery until 2012. We analyzed the evolution of 55 cases of FBSS those underwent segmental circumferential posterior fusions from June 2001 to February 2003, operated by a single surgeon and followed up during 10 years until February 2012. The patients were divided into 2 groups: In 25 patients, posterolateral fusions with Legacy™ (Medtronic, Inc. NYSE: MDT) screws and intersomatic autogenous posterior iliac crest bone graft was performed, and, in 30 patients, posterolateral fusions with the same screws and intersomatic fusion B-Twin (Biomet Spain Orthopaedics, S.L.) system was performed. In all cases, we used posterior lumbar interbody fusion (PLIF)/transforaminal lumbar interbody fusion (TLIF) approach for intervertebral graft, and the artrodesis was supplemented at intertransverse level with Autologus Growth Factor (AGF-MBA INCORPORADO, S.A.). The outcome was measured in terms of Oswestry Low Back Pain Disability Index, and the changes in pain and function were documented every year and compared from before surgery to the final follow-up visit. Preoperative and postoperative scores were available for all patients.
The average age of these patients was comparable in both groups (mean age 42.6 versus 50.2 years). The average follow-up period was 200.6 months in the first group (screws and intersomatic bone) and 184.4 months in the second group (screws and B-Twin). In the autologus bone graft group, the CT scan and Rx study revealed loss of height of intervertebral space between 25% and 45% of 24 h postoperative height of intervertebral operated disc, and the patients continued to lose the height until 20 months after the surgery. In the B Twin group, the CT scan and Rx study revealed a loss of height of the intervertebral level of 8-12% over a period of 9 months follow-up, followed by stability. A total of 31 patients (55%) had improved Oswestry Low Back Pain Disability Index >40% of the total possible points, although this did not reflect in PSI or return to work rate.
The patients with rigid fixation do well in terms of correction of lumbar lordosis, but they do not do well in terms of recurrence of pain. Furthermore, they need some kind of intervention to control pain after the first year after surgery. In patients in whom bone graft is used, although they do not maintain and sustain the lumbar lordosis in the long term, they have less recurrence of pain with less chances of intervention for pain control.
PMCID: PMC4421972  PMID: 25972934
Chronic low back pain; degenerative disc disease; failed back surgery syndrome; functional outcome; lumbar spinal fusion; spondylosis
10.  Endoscopic transforaminal decompression, interbody fusion, and percutaneous pedicle screw implantation of the lumbar spine: A case series report 
On the basis of the experiences gained from conventional open spinal procedures, a long list of desirable objectives have emerged with the evolution of the lesser invasive spinal procedures. At the top of that list is the desire to minimize the trauma of surgery. The rest of the objectives, which include reductions of operating time, surgical blood loss, hospital stay, postoperative narcotic medication, convalescence, complication rates, and escalating health care costs, as well as the desire of elderly patients to continue rigorous physical activities, largely depend on the ability to minimize the trauma of surgery. The purpose of this study was to investigate the feasibility of the least invasive lumbar decompression, interbody fusion and percutaneous pedicle screw implantation, to minimize surgical trauma without compromising the quality of the treatment outcome, as well as to minimize risk of complications.
In this case series, 60 patients with diagnoses of degenerative disc disease, degenerative motion segments with stenosis, and spondylolisthesis, in whom nonoperative treatments failed, were treated with endoscopic transforaminal decompression and interbody fusion by 1 surgeon in 2 centers. The outcome measures were as follows: operating time, intraoperative blood loss, hospital stay, Visual Analogue Scale (VAS) scores for back and leg pain, scores on the Roland-Morris Disability Questionnaire, and postoperative imaging studies. A consecutive series of patients who met the treatment criteria completed VAS forms and Roland-Morris questionnaires preoperatively. Surgical procedures included arthroscopic decompression of the foramina and the discs; endplate preparation and implantation of allograft bone chips and bone morphogenetic protein 2 on absorbable collagen sponge into the disc space; and percutaneous implantation of pedicle screws. Postoperatively, the patients again completed the VAS forms and Roland-Morris questionnaires. Their charts were reviewed for office notes, operative notes, hospital stay, medications, and imaging studies. The latest X-ray and computed tomography scan films were reviewed and analyzed. Patients were followed up for a minimum of 6 months. The literature was reviewed for comparison of outcomes.
Sixty patients met the inclusion criteria. The mean age was 52.8 years. The duration of illness averaged 5 years. Follow-up ranged from 6 to 25 months, with a mean of 12 months. Preoperative diagnoses included degenerative disc disease, degenerative motion segments with stenosis, and spondylolisthesis. The mean time in the operating room was 2 hours 54 minutes. Estimated blood loss averaged 57.6 mL. The duration of the hospital stay averaged 2.6 days. Preoperative back pain and leg pain were significantly reduced (P < .005). Forty-seven imaging studies obtained at the last visit, including X-ray and computed tomography scans, showed solid fusion in 28 patients (59.6%), stable fixation in 17 (36.2%), and osteolysis around the pedicle screws in 2 (4.2%). All patients had improvement of motor function, whereas 2 patients complained of residual numbness. In addition, 8 patients (13%) complained of residual discomfort on extension of the lumbar spine. Two patients had pedicle screw–related complications requiring surgery. A review of the literature showed that endoscopic transforaminal decompression and interbody fusion performed better than open transforaminal lumbar interbody fusion/posterior lumbar interbody fusion, minimally invasive transforaminal lumbar interbody fusion, and extreme lateral lumbar interbody fusion, with regard to most parameters studied.
The endoscopic transforaminal lumbar decompression, interbody fusion, and percutaneous pedicle screw instrumentation consistently produced satisfactory results in all demographics. It performed better than the alternative procedures for most parameters studied.
PMCID: PMC4300894  PMID: 25694885
ETDIF; Arthroscopic; Posterolateral; Interbody; Percutaneous; BMP-2
11.  Transforaminal Lumbar Interbody Fusion for Lumbar Degenerative Disorders: Mini-open TLIF and Corrective TLIF 
Neurologia Medico-Chirurgica  2015;55(7):547-556.
Minimally invasive transforaminal lumbar interbody fusion (TLIF) as a short fusion is widely accepted among the spine surgeons. However in the long fusion for degenerative kyphoscoliosis, corrective spinal fixation by an open method is thought to be frequently selected. Our objective is to study whether the mini-open TLIF and corrective TLIF contribute to the improvement of the spinal segmental and global alignment. We divided the patients who performed lumbar fixation surgery into three groups. Group 1 (G1) consisted of mini-open TLIF procedures without complication. Group 2 (G2) consisted of corrective TLIF without complication. Group 3 (G3) consisted of corrective TLIF with instrumentation-related complication postoperatively. In all groups, the lumbar lordosis (LL) highly correlated with developing surgical complications. LL significantly changed postoperatively in all groups, but was not corrected in the normal range in G3. There were statistically significant differences in preoperative and postoperative LL and mean difference between the pelvic incidence (PI) and LL between G3 and other groups. The most important thing not to cause the instrumentation-related failure is proper correction of the sagittal balance. In the cases with minimal sagittal imbalance with or without coronal imbalance, short fusion by mini-open TLIF or long fusion by corrective TLIF contributes to good clinical results if the lesion is short or easily correctable. However, if the patients have apparent sagittal imbalance with or without coronal imbalance, we should perform proper correction of the sagittal spinal alignment introducing various technologies.
PMCID: PMC4628187  PMID: 26119895
corrective transforaminal lumbar interbody fusion; lumbar lordosis; minimally invasive transforaminal lumbar interbody fusion; pelvic incidence
12.  Impact of total disc arthroplasty on the surgical management of lumbar degenerative disc disease: Analysis of the Nationwide Inpatient Sample from 2000 to 2008 
Spinal fusion is the most rapidly increasing type of lumbar spine surgery for various lumbar degenerative pathologies. The surgical treatment of lumbar spine degenerative disc disease may involve decompression, stabilization, or arthroplasty procedures. Lumbar disc athroplasty is a recent technological advance in the field of lumbar surgery. This study seeks to determine the clinical impact of anterior lumbar disc replacement on the surgical treatment of lumbar spine degenerative pathology. This is a retrospective assessment of the Nationwide Inpatient Sample (NIS).
The NIS was searched for ICD-9 codes for lumbar and lumbosacral fusion (81.06), anterior lumbar interbody fusion (81.07), and posterolateral lumbar fusion (81.08), as well as for procedure codes for revision fusion surgery in the lumbar and lumbosacral spine (81.36, 81.37, and 81.38). To assess lumbar arthroplasty, procedure codes for the insertion or replacement of lumbar artificial discs (84.60, 84.65, and 84.68) were queried. Results were assayed from 2000 through 2008, the last year with available data. Analysis was done using the lme4 package in the R programming language for statistical computing.
A total of nearly 300,000 lumbar spine fusion procedures were reported in the NIS database from 2000 to 2008; assuming a representative cross-section of the US health care market, this models approximately 1.5 million procedures performed over this time period. In 2005, the first year of its widespread use, there were 911 lumbar arthroplasty procedures performed, representing 3% of posterolateral fusions performed in this year. Since introduction, the number of lumbar spine arthroplasty procedures has consistently declined, to 653 total procedures recorded in the NIS in 2008. From 2005 to 2008, lumbar arthroplasties comprised approximately 2% of lumbar posterolateral fusions. Arthroplasty patients were younger than posterior lumbar fusion patients (42.8 ± 11.5 vs. 55.9 ± 15.1 years, P < 0.0000001). The distribution of arthroplasty procedures was even between academic and private urban facilities (48.5% and 48.9%, respectively). While rates of posterolateral lumbar spine fusion steadily grew during the period (OR 1.06, 95% CI: 1.05-1.06, P < 0.0000001), rates of revision surgery and anterior spinal fusion remained static.
The impact of lumbar arthroplasty procedures has been minimal. Measured as a percentage of more common lumbar posterior arthrodesis procedures, lumbar arthroplasty comprises only approximately 2% of lumbar spine surgeries performed in the United States. Over the first 4 years following the Food and Drug Administration (FDA) approval, the frequency of lumbar disc arthroplasty has decreased while the number of all lumbar spinal fusions has increased.
PMCID: PMC3205497  PMID: 22059134
Artificial disc; lumbar spinal fusion; total disc replacement
13.  Current concepts on spinal arthrodesis in degenerative disorders of the lumbar spine 
Back pain is a common chronic disorder that represents a large burden for the health care system. There is a broad spectrum of available treatment options for patients suffering from chronic lower back pain in the setting of degenerative disorders of the lumbar spine, including both conservative and operative approaches. Lumbar arthrodesis techniques can be divided into sub-categories based on the part of the vertebral column that is addressed (anterior vs posterior). Furthermore, one has to differentiate between approaches aiming at a solid fusion in contrast to motion-sparing techniques with the proposed advantage of a reduced risk of developing adjacent disc disease. However, the field of application and long-term outcomes of these novel motion-preserving surgical techniques, including facet arthroplasty, nucleus replacement, and lumbar disc arthroplasty, need to be more precisely evaluated in long-term prospective studies. Innovative surgical treatment strategies involving minimally invasive techniques, such as lateral lumbar interbody fusion or transforaminal lumbar interbody fusion, as well as percutaneous implantation of transpedicular or transfacet screws, have been established with the reported advantages of reduced tissue invasiveness, decreased collateral damage, reduced blood loss, and decreased risk of infection. The aim of this study was to review well-established procedures for lumbar spinal fusion with the main focus on current concepts on spinal arthrodesis and motion-sparing techniques in degenerative disorders of the lumbar spine.
PMCID: PMC3845930  PMID: 24303453
Spinal arthrodesis; Lumbar spine; Motion-sparing implants; Intrebody fusion
14.  Minimally Invasive Mini Open Split-Muscular Percutaneous Pedicle Screw Fixation of the Thoracolumbar Spine 
Orthopedic Reviews  2015;7(1):5661.
We prospectively assessed the feasibility and safety of a new percutaneous pedicle screw (PPS) fixation technique for instrumentation of the thoracic and lumbar spine in this study. All patients were operated in the prone position under general anesthesia. A 6 to 8 cm midline skin incision was made and wide subcutaneous dissection was performed. The paravertebral muscles were first dissected subperiosteally into the midline incision of the fascia for lumbar microdiscectomy with transforaminal lumbar interbody fusion cage implantation. After the secondary paramedian incisions on the fascia, the PPSs were inserted via cleavage of the multifidus muscles directly into the pedicles under fluoroscopy visualization. A total of 35 patients underwent surgery with this new surgical technique. The control group for operative time, blood loss and analgesic usage consisted of 35 randomly selected cases from our department. The control group underwent surgery via conventional pedicle screw instrumentation with paramedian fusion. All patients in the minimal invasive surgery series were ambulatory with minimal pain on the first postoperative day. The operation time and blood loss and the postoperative analgesic consumption were significantly less with this new technique. In conclusion, the minimal invasive mini open split-muscular percutaneous pedicle screw fixation technique is safe and feasible. It can be performed via a short midline skin incision and can also be combined with interbody fusion, causing minimal pain without severe muscle damage.
PMCID: PMC4387363  PMID: 25874062
minimally invasive; thoracolumbar; percutaneous; pedicle screw; spinal surgery
15.  Balloon Kyphoplasty 
Executive Summary
To review the evidence on the effectiveness and cost-effectiveness of balloon kyphoplasty for the treatment of vertebral compression fractures (VCFs).
Clinical Need
Vertebral compression fractures are one of the most common types of osteoporotic fractures. They can lead to chronic pain and spinal deformity. They are caused when the vertebral body (the thick block of bone at the front of each vertebra) is too weak to support the loads of activities of daily living. Spinal deformity due to a collapsed vertebral body can substantially affect the quality of life of elderly people, who are especially at risk for osteoporotic fractures due to decreasing bone mass with age. A population-based study across 12 European centres recently found that VCFs have a negative impact on health-related quality of life. Complications associated with VCFs are pulmonary dysfunction, eating disorders, loss of independence, and mental status change due to pain and the use of medications. Osteoporotic VCFs also are associated with a higher rate of death.
VCFs affect an estimated 25% of women over age 50 years and 40% of women over age 80 years. Only about 30% of these fractures are diagnosed in clinical practice. A Canadian multicentre osteoporosis study reported on the prevalence of vertebral deformity in Canada in people over 50 years of age. To define the limit of normality, they plotted a normal distribution, including mean and standard deviations (SDs) derived from a reference population without any deformity. They reported a prevalence rate of 23.5% in women and a rate of 21.5% in men, using 3 SDs from the mean as the limit of normality. When they used 4 SDs, the prevalence was 9.3% and 7.3%, respectively. They also found the prevalence of vertebral deformity increased with age. For people older than 80 years of age, the prevalence for women and men was 45% and 36%, respectively, using 3 SDs as the limit of normality.
About 85% of VCFs are due to primary osteoporosis. Secondary osteoporosis and neoplasms account for the remaining 15%. A VCF is operationally defined as a reduction in vertebral body height of at least 20% from the initial measurement. It is considered mild if the reduction in height is between 20% and 25%; moderate, if it is between 25% and 40%; and severs, if it is more than 40%. The most frequently fractured locations are the third-lower part of the thorax and the superior lumbar levels. The cervical vertebrae and the upper third of the thorax are rarely involved.
Traditionally, bed rest, medication, and bracing are used to treat painful VCFs. However, anti-inflammatory and narcotic medications are often poorly tolerated by the elderly and may harm the gastrointestinal tract. Bed rest and inactivity may accelerate bone loss, and bracing may restrict diaphragmatic movement. Furthermore, medical treatment does not treat the fracture in a way that ameliorates the pain and spinal deformity.
Over the past decade, the injection of bone cement through the skin into a fractured vertebral body has been used to treat VCFs. The goal of cement injection is to reduce pain by stabilizing the fracture. The secondary indication of these procedures is management of painful vertebral fractures caused by benign or malignant neoplasms (e.g., hemangioma, multiple myeloma, and metastatic cancer).
The Technology
Balloon kyphoplasty is a modified vertebroplasty technique. It is a minimally invasive procedure that aims to relieve pain, restore vertebral height, and correct kyphosis. During this procedure, an inflatable bone tamp is inserted into the collapsed vertebral body. Once inflated, the balloon elevates the end plates and thereby restores the height of the vertebral body. The balloon is deflated and removed, and the space is filled with bone cement. Creating a space in the vertebral body enables the application of more viscous cement and at a much lower pressure than is needed for vertebroplasty. This may result in less cement leakage and fewer complications. Balloons typically are inserted bilaterally, into each fractured vertebral body. Kyphoplasty usually is done under general anesthesia in about 1.5 hours. Patients typically are observed for only a few hours after the surgery, but some may require an overnight hospital stay.
Health Canada has licensed KyphX Xpander Inflatable Bone Tamp (Kyphon Inc., Sunnyvale, CA), for kyphoplasty in patients with VCFs. KyphX is the only commercially available device for percutaneous kyphoplasty. The KyphX kit uses a series of bone filler device tubes. Each bone filler device must be loaded manually with cement. The cement is injected into the cavity by pressing an inner stylet.
In the United States, the Food and Drug Administration cleared the KyphX Inflatable Bone Tamp for marketing in July 1998. CE (Conformité European) marketing was obtained in February 2000 for the reduction of fracture and/or creation of a void in cancellous bone.
Review Strategy
The aim of this literature review was to evaluate the safety and effectiveness of balloon kyphoplasty in the treatment of painful VCFs.
INAHTA, Cochrane CCTR (formerly Cochrane Controlled Trials Register), and DSR were searched for health technology assessment reports. In addition, MEDLINE, EMBASE, and MEDLINE In-Process & Other Non-Indexed Citations were searched from January 1, 2000 to September 21, 2004. The search was limited to English-language articles and human studies.
The positive end points selected for this assessment were as follows:
Reduction in pain scores
Reduction in vertebral height loss
Reduction in kyphotic (Cobb) angle
Improvement in quality of life scores
The search did not yield any health technology assessments on balloon kyphoplasty. The search yielded 152 citations, including those for review articles. No randomized controlled trials (RCTs) on balloon kyphoplasty were identified. All of the published studies were either prospective cohort studies or retrospective studies with no controls. Eleven studies (all case series) met the inclusion criteria. There was also a comparative study published in German that had been translated into English.
Summary of Findings
The results of the 1 comparative study (level 3a evidence) that was included in this review showed that, compared with conservative medical care, balloon kyphoplasty significantly improved patient outcomes.
Patients who had balloon kyphoplasty reported a significant reduction in pain that was maintained throughout follow-up (6 months), whereas pain scores did not change in the control group. Patients in the balloon kyphoplasty group did not need pain medication after 3 days. In the control group, about one-half of the patients needed more pain medication in the first 4 weeks after the procedure. After 6 weeks, 82% of the patients in the control group were still taking pain medication regularly.
Adjacent fractures were more frequent in the control group than in the balloon kyphoplasty group.
The case series reported on several important clinical outcomes.
Pain: Four studies on osteoporosis patients and 1 study on patients with multiple myeloma/primary cancers used the Visual Analogue Scale (VAS) to measure pain before and after balloon kyphoplasty. All of these studies reported that patients had significantly less pain after the procedure. This was maintained during follow-up. Two other studies on patients with osteoporosis also used the VAS to measure pain and found a significant improvement in pain scores; however, they did not provide follow-up data.
Vertebral body height: All 5 studies that assessed vertebral body height in patients with osteoporosis reported a significant improvement in vertebral body height after balloon kyphoplasty. One study had 1-year follow-up data for 26 patients. Vertebral body height was significantly better at 6 months and 1 year for both the anterior and midline measurements.
Two studies reported that vertebral body height was restored significantly after balloon kyphoplasty for patients with multiple myeloma or metastatic disease. In another study, the researchers reported complete height restoration in 9% of patients, a mean 56% height restoration in 60% of patients, and no appreciable height restoration in 31% of the patients who received balloon kyphoplasty.
Kyphosis correction: Four studies that assessed Cobb angle before and after balloon kyphoplasty in patients with osteoporosis found a significant reduction in degree of kyphosis after the procedure. In these studies, the differences between preoperative and postoperative Cobb angles were 3.4°, 7°, 8.8°, and 9.9°.
Only 1 study investigated kyphosis correction in patients with multiple myeloma or metastatic disease. The authors reported a significant improvement (5.2°) in local kyphosis.
Quality of life: Four studies used the Short Form 36 (SF-36) Health Survey Questionnaire to measure the quality of life in patients with osteoporosis after they had balloon kyphoplasty. A significant improvement in most of the domains of the SF-36 (bodily pain, social functioning, vitality, physical functioning, mental health, and role functioning) was observed in 2 studies. One study found that general health declined, although not significantly, and another found that role emotional declined.
Both studies that used the Oswestry Disability Index found that patients had a better quality of life after balloon kyphoplasty. In one study, this improvement was statistically significant. In another study, researchers found that quality of life after kyphoplasty improved significantly, as measured with the Roland-Morris Disability Questionnaire. Yet another study used a quality of life questionnaire and found that 62% of the patients that had balloon kyphoplasty had returned to normal activities, whereas 2 patients had reduced mobility.
To measure quality of life in patients with multiple myeloma or metastatic disease, one group of researchers used the SF-36 and found significantly better scores on bodily pain, physical functioning, vitality, and social functioning after kyphoplasty. However, the scores for general health, mental health, role physical, and role emotional had not improved. A study that used the Oswestry Disability Index reported that patients’ scores were better postoperatively and at 3 months follow-up.
These were the main findings on complications in patients with osteoporosis:
The bone cement leaked in 37 (6%) of 620 treated fractures.
There were no reports of neurological deficits.
There were no reports of pulmonary embolism due to cement leakage.
There were 6 cases of cardiovascular events in 362 patients:
3 (0.8%) patients had myocardial infarction.
3 (0.8%) patients had cardiac arrhythmias.
There was 1 (0.27%) case of pulmonary embolism due to deep venous thrombosis.
There were 20 (8.4%) cases of new fractures in 238 patients.
For patients with multiple myeloma or metastatic disease, these were the main findings:
The bone cement leaked in 12 (9.6%) of 125 procedures.
There were no reports of neurological deficits.
Economic Analysis
Balloon kyphoplasty requires anesthesia. Standard vertebroplasty requires sedation and an analgesic. Based on these considerations, the professional fees (Cdn) for each procedure is shown in Table 1.
Professional Fees for Standard Vertebroplasty and Balloon Kyphoplasty
Balloon kyphoplasty has a sizable device cost add-on of $3,578 (the device cost per case) that standard vertebroplasty does not have. Therefore, the up-front cost (i.e., physician’s fees and device costs) is $187 for standard vertebroplasty and $3,812 for balloon kyphoplasty. (All costs are in Canadian currency.)
There are also “downstream costs” of the procedures, based on the different adverse outcomes associated with each. This includes the risk of developing new fractures (21% for vertebroplasty vs. 8.4% for balloon kyphoplasty), neurological complications (3.9% for vertebroplasty vs. 0% for balloon kyphoplasty), pulmonary embolism (0.1% for vertebroplasty vs. 0% for balloon kyphoplasty), and cement leakage (26.5% for vertebroplasty vs. 6.0% for balloon kyphoplasty). Accounting for these risks, and the base costs to treat each of these complications, the expected downstream costs are estimated at less than $500 per case. Therefore, the expected total direct medical cost per patient is about $700 for standard vertebroplasty and $4,300 for balloon kyphoplasty.
Kyphon, the manufacturer of the inflatable bone tamps has stated that the predicted Canadian incidence of osteoporosis in 2005 is about 29,000. The predicted incidence of cancer-related vertebral fractures in 2005 is 6,731. Based on Ontario having about 38% of the Canadian population, the incidence in the province is likely to be about 11,000 for osteoporosis and 2,500 for cancer-related vertebral fractures. This means there could be as many as 13,500 procedures per year in Ontario; however, this is highly unlikely because most of the cancer-related fractures likely would be treated with medication. Given a $3,600 incremental direct medical cost associated with balloon kyphoplasty, the budget impact of adopting this technology could be as high as $48.6 million per year; however, based on data from the Provider Services Branch, about 120 standard vertebroplasties are done in Ontario annually. Given these current utilization patterns, the budget impact is likely to be in the range of $430,000 per year. This is because of the sizable device cost add-on of $3,578 (per case) for balloon kyphoplasty that standard vertebroplasty does not have.
Policy Considerations
Other treatments for osteoporotic VCFs are medical management and open surgery. In cases without neurological involvement, the medical treatment of osteoporotic VCFs comprises bed rest, orthotic management, and pain medication. However, these treatments are not free of side effects. Bed rest over time can result in more bone and muscle loss, and can speed the deterioration of the underlying condition. Medication can lead to altered mood or mental status. Surgery in these patients has been limited because of its inherent risks and invasiveness, and the poor quality of osteoporotic bones. However, it may be indicated in patients with neurological deficits.
Neither of these vertebral augmentation procedures eliminates the need for aggressive treatment of osteoporosis. Osteoporotic VCFs are often under-diagnosed and under-treated. A survey of physicians in Ontario (1) who treated elderly patients living in long-term care homes found that although these physicians were aware of the rates of osteoporosis in these patients, 45% did not routinely assess them for osteoporosis, and 26% did not routinely treat them for osteoporosis.
Management of the underlying condition that weakens the vertebral bodies should be part of the treatment plan. All patients with osteoporosis should be in a medical therapy program to treat the underlying condition, and the referring health care provider should monitor the clinical progress of the patient.
The main complication associated with vertebroplasty and balloon kyphoplasty is cement leakage (extravertebral or vascular). This may result in more patient morbidity, longer hospitalizations, the need for open surgery, and the use of pain medications, all of which have related costs. Extravertebral cement leakage can cause neurological complications, like spinal cord compression, nerve root compression, and radiculopathy. In some cases, surgery is required to remove the cement and release the nerve. The rate of cement leakage is much lower after balloon kyphoplasty than after vertebroplasty. Furthermore, the neurological complications seen with vertebroplasty have not seen in the studies of balloon kyphoplasty. Rarely, cement leakage into the venous system will cause a pulmonary embolism. Finally, compared with vertebroplasty, the rate of new fractures is lower after balloon kyphoplasty.
Diffusion – International, National, Provincial
In Canada, balloon kyphoplasty has not yet been funded in any of the provinces. The first balloon kyphoplasty performed in Canada was in July 2004 in Ontario.
In the United States, the technology is considered by some states as medically reasonable and necessary for the treatment of painful vertebral body compression fractures.
There is level 4 evidence that balloon kyphoplasty to treat pain associated with VCFs due to osteoporosis is as effective as vertebroplasty at relieving pain. Furthermore, the evidence suggests that it restores the height of the affected vertebra. It also results in lower fracture rates in other vertebrae compared with vertebroplasty, and in fewer neurological complications due to cement leakage compared with vertebroplasty. Balloon kyphoplasty is a reasonable alternative to vertebroplasty, although it must be reiterated that this conclusion is based on evidence from level 4 studies.
Balloon kyphoplasty should be restricted to facilities that have sufficient volumes to develop and maintain the expertise required to maximize good quality outcomes. Therefore, consideration should be given to limiting the number of facilities in the province that can do balloon kyphoplasty.
PMCID: PMC3387743  PMID: 23074451
16.  Clinical Outcomes of Posterior Lumbar Interbody Fusion versus Minimally Invasive Transforaminal Lumbar Interbody Fusion in Three-Level Degenerative Lumbar Spinal Stenosis 
BioMed Research International  2016;2016:9540298.
The aim of this study was to directly compare the clinical outcomes of posterior lumbar interbody fusion (PLIF) and minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) in three-level lumbar spinal stenosis. This retrospective study involved a total of 60 patients with three-level degenerative lumbar spinal stenosis who underwent MIS-TLIF or PLIF from January 2010 to February 2012. Back and leg visual analog scale (VAS), Oswestry Disability Index (ODI), and Short Form-36 (SF-36) scale were used to assess the pain, disability, and health status before surgery and postoperatively. In addition, the operating time, estimated blood loss, and hospital stay were also recorded. There were no significant differences in back VAS, leg VAS, ODI, SF-36, fusion condition, and complications at 12-month follow-up between the two groups (P > 0.05). However, significantly less blood loss and shorter hospital stay were observed in MIS-TLIF group (P < 0.05). Moreover, patients undergoing MIS-TLIF had significantly lower back VAS than those in PLIF group at 6-month follow-up (P < 0.05). Compared with PLIF, MIS-TLIF might be a prior option because of noninferior efficacy as well as merits of less blood loss and quicker recovery in treating three-level lumbar spinal stenosis.
PMCID: PMC5056235  PMID: 27747244
17.  MIS Fusion of the SI Joint: Does Prior Lumbar Spinal Fusion Affect Patient Outcomes? 
Sacroiliac (SI) joint pain is a challenging condition to manage as it can mimic discogenic or radicular low back pain, and present as low back, hip, groin and/or buttock pain. Patients may present with a combination of lumbar spine and SI joint symptoms, further complicating the diagnosis and treatment algorithm [1-3]. SI joint pain after lumbar spinal fusion has been reported in the literature. Both clinical and biomechanical studies show the SI joint to be susceptible to increased motion and stress at the articular surface with up to 40-75% of patients developing significant SI joint degeneration after 5 years.
In a recent case series study of 50 patients who underwent minimally invasive SI joint arthrodesis, 50% had undergone previous lumbar spinal fusion and 18% had symptomatic lumbar spine pathology treated conservatively [4].
The purpose of this study is to determine if history of previous lumbar fusion or lumbar pathology affects patient outcomes after MIS SI joint fusion surgery.
We report on 40 patients with 24 month follow up treated with MIS SI joint fusion using a series of triangular porous plasma coated titanium implants (iFuse, SI-Bone, Inc. San Jose, CA). Outcomes using a numerical rating scale (NRS) for pain were obtained at 3-, 6-, 12- and 24 month follow up intervals. Additionally, patient satisfaction was collected at the latest follow up interval. Patients were separated into 3 cohorts: 1) underwent prior lumbar spine fusion (PF), 2) no history of previous lumbar spine fusion (NF), 3) no history of previous lumbar spine fusion with symptomatic lumbar spine pathology treated conservatively (LP). A repeated measures analysis of variance (rANOVA) was used to determine if the change in NRS pain scores differed across timepoints and subgroups. A decrease in NRS by 2 points was deemed clinically significant [5].
Mean age was 54 (±13) years and varied slightly but not statistically between groups. All subgroups experienced a clinically and statistically significant reduction in pain at all time points (mean change >2 points, p<0.001). There was a statistically significant effect of cohort (p=0.045), with the NF cohort (no prior lumbar spinal fusion) having a somewhat greater decrease in pain (by approximately 1 point) compared to the other 2 groups (PF and LP).Patient reported satisfaction by cohort was: 89% (NF), 92% (PF) and 63% (LP).Overall satisfaction rate was 87%.
Discussion and Conclusion:
Patients with SI joint pain, regardless of prior lumbar spine fusion history, show significant improvement in pain after minimally invasive SI joint fusion. The presence of symptomatic lumbar spine pathology potentially confounds the treatment affect, as patients may not be able to discriminate between symptoms arising from the SI joint and the lumbar spine. These patients expressed a lower satisfaction with surgery. Patients without other confounding lumbar spine pathology and who have not undergone previous spine surgery tend to be younger and experience a greater reduction in pain.
PMCID: PMC3664440  PMID: 23730380
Sacroiliac (SI) joint; lumbar fusion; minimally invasive surgery; MIS arthrodesis.
18.  The Evolution and Advancement of Endoscopic Foraminal Surgery: One Surgeon's Experience Incorporating Adjunctive Techologies 
SAS Journal  2007;1(3):108-117.
Endoscopic spine surgery has evolved gradually through improvements in endoscope design, instrumentation, and surgical techniques. The ability to visualize and treat painful pathology endoscopically through the foramen has opened the door for the diagnosis and treatment of degenerative conditions of the lumbar spine (from T10 to S1). Other endoscopic techniques for treating a painful disc have been focused on a posterior approach and has been compared with micro–lumbar discectomy. These procedures have not been more effective than open microdiscectomy but are less invasive, have less surgical morbidity, and allow for more rapid surgical recovery. Spinal decompression and fusion was the fallback procedure when nonsurgical treatment or discectomy failed to relieve sciatica and back pain. Foraminal endoscopic surgery, however, provides a truly minimally invasive alternative approach to the pathoanatomy of the lumbar spine because it preserves the multifidus muscle, maintains motion, and eliminates or, at worst, delays the need for fusion.
The following developments helped facilitate the evolution of a transforaminal endoscopic surgery procedure for disc herniations from a foraminal disc decompression, also known as percutaneous endoscopic lumbar discectomy, to a more complete foraminal surgical technique that can address spinal stenosis and spinal instability. This expanded capability gives foraminal endoscopic surgery distinct advantages and flexibility for certain painful degenerative conditions compared with open surgery. Advancement of the technique occurred when needle trajectory and placement was refined to better target each type of herniation with precise needle and cannula positioning directed at the herniation. New instrumentation and inclusion of a biportal technique also facilitated removal of extruded, migrated, and sequestered disc herniations. The further development of foraminoscopes with larger working channels and high speed burrs to remove bone more efficiently, along with recognition of foraminal pathoanatomy in the foramen, led to the identification and treatment of other painful degenerative conditions of the lumbar spine such as failed back surgery syndrome, recurrent disc herniations, lateral foraminal stenosis, degenerative spondylolisthesis, and isthmic spondylolisthesis.
A summary of the endoscopic techniques currently used and trademarked by the author as the YESS technique include: (1) a published protocol for optimal needle and instrument placement calculated by lines drawn on the skin from the C-arm image; (2) evocative chromodiscography by the operating surgeon with nonionic radiologic contrast and indigo carmine dye to confirm concordant pain production and to stain tissue in contact with the injectate; (3) selective endoscopic discectomy, which targets the removal of loose degenerative nucleus stained differentially by indigo carmine dye; (4) thermal annuloplasty, a visualized radiofrequency thermal modulation of disc and annular defects guided by vital tissue staining; (5) endoscopic foraminoplasty, a decompression of the lateral and subarticular recess, including disc and foraminal degenerative and isthmic spondylolisthesis; (6) visually and radiologically guided exploration of the epidural space; (7) probing the hidden zone of MacNab for normal nerves (and branches of spinal nerves known as furcal nerves) versus anomalous autonomic nerves in the foramen; and (8) a uniportal and biportal technique for inside-out removal of extruded and sequestered nucleus pulposus.
Endoscopic foraminal surgical procedures are not limited to disc decompression. The approaches and techniques allow access to the lumbar spine for treatment of conditions ranging from discogenic pain to failed back surgery syndrome (most commonly caused by residual or recurrent disc herniation and lateral recess stenosis). More than 3000 patients have undergone endoscopic posterolateral surgical exploration and decompression by the author since 1991. The first 80 patients reported formed the basis for expansion of techniques as new instruments and adjunctive therapy methods were added to selective endoscopic discectomy and thermal annuloplasty. New anatomic and pathoanatomic conditions were reported as they were encountered.
New skills will become desirable and necessary for the spine surgeon to keep up with endoscopic technology in spine care. The emphasis is on visualization of painful pathoanatomy and preservation of mobility. A new focus is on nucleus replacement, annular repair, annular reinforcement, biologics, and even transforaminal interbody fusion as the procedure of last resort. The transforaminal surgical approach to the lumbar spine can allow for minimally invasive access without negatively affecting and destabilizing the multifidus muscle.
PMCID: PMC4365579  PMID: 25802587
Chymopapain; arthroscopic microdiscectomy; laser disc decompression; evocative chromodiscography; selective endoscopic discectomy; endoscopic thermal annuloplasty; endoscopic foraminoplasty
19.  Economics of less invasive spinal surgery: an analysis of hospital cost differences between open and minimally invasive instrumented spinal fusion procedures during the perioperative period 
There is great debate about the costs and benefits of technology-driven medical interventions such as instrumented lumbar fusion. With most analyses using charge data, the actual costs incurred by medical institutions performing these procedures are not well understood. The object of the current study was to examine the differences in hospital operating costs between open and minimally invasive spine surgery (MIS) during the perioperative period.
Data were collected in the form of a prospective registry from a community hospital after specific Institutional Review Board approval was obtained. The analysis included consecutive adult patients being surgically treated for degenerative conditions of the lumbar spine, with either an MIS or open approach for two-level instrumented lumbar fusion. Patient outcomes and costs were collected for the perioperative period. Hospital operating costs were grouped by hospitalization/operative procedure, transfusions, reoperations, and residual events (health care interactions).
One hundred and one open posterior lumbar interbody fusion (Open group) and 109 MIS patients were treated primarily for stenosis coupled with instability (39.6% and 59.6%, respectively). Mean total hospital costs were $27,055.53 for the Open group and $24,320.16 for the MIS group. This represents a statistically significant cost savings of $2,825.37 (10.4% [95% confidence interval: $522.51–$5,128.23]) when utilizing MIS over traditional Open techniques. Additionally, residual events, complications, and blood transfusions were significantly more frequent in the Open group, compared to the MIS group.
Conclusions/level of evidence
Utilizing minimally invasive techniques for instrumented spinal fusion results in decreased hospital operating costs compared to similar open procedures in the early perioperative period. Additionally, patient benefits of minimally invasive techniques include significantly less blood loss, shorter hospital stays, lower complication rate, and a lower number of residual events. Long-term outcome comparisons are needed to evaluate the efficacy of the two treatments. Level of evidence: III
Clinical relevance
This work represents a true cost-of-operating comparison between open and MIS approaches for lumbar spine fusion, which has relevance to surgeons, hospitals and payers in medical decision-making.
PMCID: PMC3430081  PMID: 22952415
lumbar; degenerative; complications; MIS; residual events
20.  Gait in thoracolumbar/lumbar adolescent idiopathic scoliosis: effect of surgery on gait mechanisms 
European Spine Journal  2010;19(7):1179-1188.
For patients whose scoliosis progresses, surgery remains the ultimate way to correct and stabilise the deformity while maintaining as many mobile spinal segments as possible. In thoracolumbar/lumbar adolescent idiopathic scoliosis (AIS), the spinal fusion has to be extended to the lumbar spine. The use of anterior spinal fusion (ASF) instead of the classic posterior fusion (PSF) may preserve more distal spinal levels in attempt to limit the consequences of surgery on trunk mobility. The effects of surgery on body shape, pain and the decompensation phenomenon have all been well evaluated. Very few studies have addressed the effect of ASF or PSF on basic activities, such as walking. Before any treatment, AIS patients already have reduced pelvis, hip and shoulder motion when walking at a normal speed compared with adolescents without scoliosis (control group). Additionally, they have longer contraction time of the lumbar and pelvic muscles leading to an excessive energy cost and reduced muscle efficiency. In addition, if these changes are associated with spinal stiffness, spinal fusion could further negatively affect this pre-surgical inefficient walk. The goals of this study were (a) to compare pre- and 1-year post-surgery conditions in order to assess the effects of spinal arthrodesis on gait parameters and (b) to compare the anterior versus the posterior surgical approaches. Nineteen young females with thoracolumbar/lumbar AIS were assessed by radiological and clinical examination and by conventional gait analysis before surgery and at almost 12 months after surgery. Seven subjects underwent surgery using ASF and 12 using PSF. Three-dimensional gait analysis was performed on a motor-driven treadmill at spontaneous self-selected speed to record kinematic, electromyographic (EMG), mechanical and energetic measurements synchronously. Although it was expected that the instrumentation would modify the characteristics of normal walking, this study showed that surgery does not induce asymmetric gait or any significant differences between the ASP and the PSF surgery groups. One year after surgery, the changes observed consisted of improvements in the gait and mechanical parameters. In the PSF group, 11–14 vertebrae were fused while only 3–4 were fused in the ASF group. In both AIS groups, step length was increased by 4% and cadence reduced by 2%. There was a slight increase in pelvis and hip frontal motion. Only the transverse shoulder motion was mildly decreased by 1.5°. All the other gait parameters were left unchanged or were improved by surgery. Notably, the EMG timing activity did not change. The total muscular mechanical work (Wtot) increased by 6% mainly due to the external work (Wext), i.e. the work performed by the body muscles to move the body in its surroundings. The energy cost, although showing a tendency towards a reduction, remained globally excessive, probably due to the excessive co-contraction of the lumbo-pelvic muscles.
PMCID: PMC2900025  PMID: 20148341
Scoliosis; Gait; Energy; Surgery
21.  Mid-term clinical results of minimally invasive decompression and posterolateral fusion with percutaneous pedicle screws versus conventional approach for degenerative spondylolisthesis with spinal stenosis 
European Spine Journal  2011;21(6):1171-1177.
In order to minimize perioperative invasiveness and improve the patients’ functional capacity of daily living, we have performed minimally invasive lumbar decompression and posterolateral fusion (MIS-PLF) with percutaneous pedicle screw fixation for degenerative spondylolisthesis with spinal stenosis. Although several minimally invasive fusion procedures have been reported, no study has yet demonstrated the efficacy of MIS-PLF in degenerative spondylolisthesis of the lumbar spine. This study prospectively compared the mid-term clinical outcome of MIS-PLF with those of conventional PLF (open-PLF) focusing on perioperative invasiveness and patients’ functional capacity of daily living.
Materials and methods
A total of 80 patients received single-level PLF for lumbar degenerative spondylolisthesis with spinal stenosis. There were 43 cases of MIS-PLF and 37 cases of open-PLF. The surgical technique of MIS-PLF included making a main incision (4 cm), and neural decompression followed by percutaneous pedicle screwing and rod insertion. The posterolateral gutter including the medial transverse process was decorticated and iliac bone graft was performed. The parameters analyzed up to a 2-year period included the operation time, intra and postoperative blood loss, Oswestry-Disability Index (ODI), Roland-Morris Questionnaire (RMQ), the Japanese Orthopaedic Association score, and the visual analogue scale of low back pain. The fusion rate and complications were also reviewed.
The average operation time was statistically equivalent between the two groups. The intraoperative blood loss was significantly less in the MIS-PLF group (181 ml) when compared to the open-PLF group (453 ml). The postoperative bleeding on day 1 was also less in the MIS-PLF group (210 ml) when compared to the open-PLF group (406 ml). The ODI and RMQ scores rapidly decreased during the initial postoperative 2 weeks in the MIS-PLF group, and consistently maintained lower values than those in the open-PLF group at 3, 6, 12, and 24 months postoperatively. The fusion rate was statistically equivalent between the two groups (98 vs. 100%), and no major complications occurred.
The MIS-PLF utilizing a percutaneous pedicle screw system is less invasive compared to conventional open-PLF. The reduction in postoperative pain led to an increase in activity of daily living (ADL), demonstrating rapid improvement of several functional parameters. This superiority in the MIS-PLF group was maintained until 2 years postoperatively, suggesting that less invasive PLF offers better mid-term results in terms of reducing low back pain and improving patients’ functional capacity of daily living. The MIS-PLF utilizing percutaneous pedicle screw fixation serves as an alternative technique, eliminating the need for conventional open approach.
PMCID: PMC3366131  PMID: 22173610
Minimally invasive spine surgery; Posterolateral fusion; Percutaneous pedicle screw; Degenerative spondylolisthesis; Lumbar spine
22.  Functional outcome after posterolateral spinal fusion using pedicle screws: comparison between primary and salvage procedure 
European Spine Journal  1998;7(4):321-327.
Lumbar spinal fusion is a commonly performed surgical procedure, yet both the indications for its performance and its results remain controversial. It is generally believed that apart from situations where obvious measurable instability exists, a repeat surgical procedure such as spinal fusion does not improve the functional outcome in more than an average of 50% of cases. The aim of this study was to analyse functional outcome after posterolateral lumbar or lumbosacral spinal fusion, comparing primary and salvage procedures. It was designed as a prospective case/referent study with a 2-year follow-up. A total of 39 patients underwent a short posterior fusion with Cotrel-Dubousset (CD) pedicle screw fixation after earlier surgery of the lumbar spine. Two patients were erroneously omitted from the study at the index, so 37 patients were included in the salvage group. In the same period, 69 patients underwent lumbar fusion with pedicle screw fixation (CD) as primary surgery (referent group). Functional outcome was assessed by means of the Dallas Pain Questionnaire preoperatively and 1 and 2 years postoperatively. Fusion rates were determined by ordinary X-ray evaluation by two independent observers. Patients who had undergone previous spinal surgery had a significant improvement in functional outcome in terms of daily activity, work and leisure-time activities and anxiety/depression. With regard to social functioning, a significantly inferior outcome was found after the salvage procedure. The return-to-work rates at 2 years after surgery were 50% in the salvage group and 53% in the referent group. There was a significant correlation between radiological evaluation of the fusion mass and the functional outcome. The fusion rate was 76% in the salvage group and 72% in the referent group. This study demonstrates that a posterolateral spinal fusion can be effectively used as a salvage procedure. The functional and radiological outcome of the patients with revision surgery did not differ from those of the group of patients who underwent primary surgery. There was, however a clear indication of inferior social functioning after revision surgery.
PMCID: PMC3611274  PMID: 9765041
Key words Lumbar fusion; Pedicle; screw; Reoperation; Functional; outcome; Dallas Pain; Questionnaire; Revision surgery
23.  Minimally Invasive Surgical Approaches in the Management of Tuberculosis of the Thoracic and Lumbar Spine 
Spinal tuberculosis is the most common form of skeletal tuberculosis. Various approaches have been described for surgical management of spinal tuberculosis, but many entail wide exposures with attendant morbidity; whether minimally invasive surgical (MIS) approaches are suitable is unknown.
We evaluated (1) neurologic results, (2) radiographic results, and (3) complications in patients with thoracic and lumbar spinal tuberculosis treated with two MIS approaches.
We retrospectively evaluated 22 patients with thoracic and lumbar tuberculosis managed surgically from October 2008 to February 2011 using MIS methods; one patient was lost to followup, leaving 21 patients with a minimum followup of 15 months (mean, 30 months; range, 15–59 months) for analysis. MIS approaches were used for patients with disease below D6 and minimum pedicle diameters of 4.5 mm to permit percutaneous screw placement. The MIS approach was divided into two groups depending on the extent of destruction of the vertebral body: a posterior-only group (n = 9), where posterior transpedicular decompression sufficed, and the hybrid group (n = 12), requiring anterior débridement and ventral-column reconstruction by conventional or mini-open thoracotomy. All but two patients with more than two contiguous bodies involvement underwent MIS posterior fixation by percutaneous transpedicular screws. Plain radiographs were evaluated for deformity correction and correction maintenance. Neurologic recovery and complications were ascertained by chart review.
All patients with neurologic deficits recovered completely with no motor deficits at followup; 13% improved by three grades, 53% by two grades, and 33% by one grade. Mean correction was 2.5° (thoracic) and 8° (lumbar) in the posterior-only group and 4.2° in the hybrid group. Some correction loss occurred with healing (2° and 1.6° in the posterior-only and hybrid groups, respectively), but in none of those who had fixation did this progress to more than preoperative status. Two of 22 patients (9%) had complications. One had a malposition of L5 screw causing painful radiculopathy without motor deficit and required repositioning. The other had an intraoperative dural tear repaired by onlay fascial patch and cerebrospinal fluid diversion. There were no approach-related complications, neurologic deterioration, or implant fatigue at last followup.
We found evidence of neurologic recovery, avoidance of deformity progression, and few complications with these MIS approaches. Comparative trials are called for between open and MIS approaches for patients with spinal tuberculosis.
Level of Evidence
Level IV, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.
PMCID: PMC4016460  PMID: 24474323
24.  Minimally invasive versus open transforaminal lumbar interbody fusion 
Available clinical data are insufficient for comparing minimally invasive (MI) and open approaches for transforaminal lumbar interbody fusion (TLIF). To date, a paucity of literature exists directly comparing minimally invasive (MI) and open approaches for transforaminal lumbar interbody fusion (TLIF). The purpose of this study was to directly compare safety and effectiveness for these two surgical approaches.
Materials and Methods
Open or minimally invasive TLIF was performed in 63 and 76 patients, respectively. All consecutive minimally invasive TLIF cases were matched with a comparable cohort of open TLIF cases using three variables: diagnosis, number of spinal levels, and history of previous lumbar surgery. Patients were treated for painful degenerative disc disease with or without disc herniation, spondylolisthesis, and/or stenosis at one or two spinal levels. Clinical outcome (self-report measures, e.g., visual analog scale (VAS), patient satisfaction, and MacNab's criteria), operative data (operative time, estimated blood loss), length of hospitalization, and complications were assessed. Average follow-up for patients was 37.5 months.
The mean change in VAS scores postoperatively was greater (5.2 vs. 4.1) in theopen TLIF patient group (P = 0.3). MacNab's criteria score was excellent/good in 67% and 70% (P = 0.8) of patients in open and minimally invasive TLIF groups, respectively. The overall patient satisfaction was 72.1% and 64.5% (P = 0.4) in open and minimally invasive TLIF groups, respectively. The total mean operative time was 214.9 min for open and 222.5 min for minimally invasive TLIF procedures (P = 0.5). The mean estimated blood loss for minimally invasive TLIF (163.0 ml) was significantly lower (P < 0.0001) than the open approach (366.8 ml). The mean duration of hospitalization in the minimally invasive TLIF (3 days) was significantly shorter (P = 0.02) than the open group (4.2 days). The total rate of neurological deficit was 10.5% in the minimally invasive TLIF group compared to 1.6% in the open group (P = 0.02).
Minimally invasive TLIF technique may provide equivalent long-term clinical outcomes compared to open TLIF approach in select population of patients. The potential benefit of minimized tissue disruption, reduced blood loss, and length of hospitalization must be weighted against the increased rate of neural injury-related complications associated with a learning curve.
PMCID: PMC2908364  PMID: 20657693
Clinical outcomes; Complications; Degenerative lumbar spine; Lumbar fusion; Minimally invasive approach; Open approach; Transforaminal lumbar interbody fusion
25.  Trunk Control Ability after Minimally Invasive Lumbar Fusion Surgery during the Early Postoperative Phase 
Journal of Physical Therapy Science  2014;26(8):1165-1171.
[Purpose] Lumbar fusion has been used for spinal disorders when conservative treatment fails. The minimally invasive approach causes minimal damage to the back muscles and shortens the postoperative recovery time. However, evidence regarding functional recovery in patients after minimally invasive lumbar spinal fusion is limited. The purpose of this study was to investigate how trunk control ability is affected after minimally invasive lumbar fusion surgery during the early postoperative phase. [Subjects and Methods] Sixteen patients and 16 age- and sex-matched healthy participants were recruited. Participants were asked to perform a maximum forward reaching task and were evaluated 1 day before and again 1 month after the lumbar fusion surgery. Center of pressure (COP) displacement, back muscle strength, and scores for the Visual Analog Scale, and Chinese version of the modified Oswestry Disability Index (ODI) were recorded. [Results] The healthy control group exhibited more favorable outcomes than the patient group both before and after surgery in back strength, reaching distance, reaching velocity, and COP displacement. The patient group improved significantly after surgery in all clinical outcome measurements. However, reaching distance decreased, and the reaching velocity as well as COP displacement did not differ before and after surgery. [Conclusion] The LBP patients with lumbar fusion surgery showed improvement in pain intensity 1 month after surgery but no improvement in trunk control during forward reaching. The results provide evidence that the back muscle strength was not fully recovered in patients 1 month after surgery and limited their ability to move their trunk forward.
PMCID: PMC4155213  PMID: 25202174
Biomechanics; Postural balance; Low back pain

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