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1.  Artificial Discs for Lumbar and Cervical Degenerative Disc Disease –Update 
Executive Summary
Objective
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).
Conclusions
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.  Utilization of DXA Bone Mineral Densitometry in Ontario 
Executive Summary
Issue
Systematic reviews and analyses of administrative data were performed to determine the appropriate use of bone mineral density (BMD) assessments using dual energy x-ray absorptiometry (DXA), and the associated trends in wrist and hip fractures in Ontario.
Background
Dual Energy X-ray Absorptiometry Bone Mineral Density Assessment
Dual energy x-ray absorptiometry bone densitometers measure bone density based on differential absorption of 2 x-ray beams by bone and soft tissues. It is the gold standard for detecting and diagnosing osteoporosis, a systemic disease characterized by low bone density and altered bone structure, resulting in low bone strength and increased risk of fractures. The test is fast (approximately 10 minutes) and accurate (exceeds 90% at the hip), with low radiation (1/3 to 1/5 of that from a chest x-ray). DXA densitometers are licensed as Class 3 medical devices in Canada. The World Health Organization has established criteria for osteoporosis and osteopenia based on DXA BMD measurements: osteoporosis is defined as a BMD that is >2.5 standard deviations below the mean BMD for normal young adults (i.e. T-score <–2.5), while osteopenia is defined as BMD that is more than 1 standard deviation but less than 2.5 standard deviation below the mean for normal young adults (i.e. T-score< –1 & ≥–2.5). DXA densitometry is presently an insured health service in Ontario.
Clinical Need
 
Burden of Disease
The Canadian Multicenter Osteoporosis Study (CaMos) found that 16% of Canadian women and 6.6% of Canadian men have osteoporosis based on the WHO criteria, with prevalence increasing with age. Osteopenia was found in 49.6% of Canadian women and 39% of Canadian men. In Ontario, it is estimated that nearly 530,000 Ontarians have some degrees of osteoporosis. Osteoporosis-related fragility fractures occur most often in the wrist, femur and pelvis. These fractures, particularly those in the hip, are associated with increased mortality, and decreased functional capacity and quality of life. A Canadian study showed that at 1 year after a hip fracture, the mortality rate was 20%. Another 20% required institutional care, 40% were unable to walk independently, and there was lower health-related quality of life due to attributes such as pain, decreased mobility and decreased ability to self-care. The cost of osteoporosis and osteoporotic fractures in Canada was estimated to be $1.3 billion in 1993.
Guidelines for Bone Mineral Density Testing
With 2 exceptions, almost all guidelines address only women. None of the guidelines recommend blanket population-based BMD testing. Instead, all guidelines recommend BMD testing in people at risk of osteoporosis, predominantly women aged 65 years or older. For women under 65 years of age, BMD testing is recommended only if one major or two minor risk factors for osteoporosis exist. Osteoporosis Canada did not restrict its recommendations to women, and thus their guidelines apply to both sexes. Major risk factors are age greater than or equal to 65 years, a history of previous fractures, family history (especially parental history) of fracture, and medication or disease conditions that affect bone metabolism (such as long-term glucocorticoid therapy). Minor risk factors include low body mass index, low calcium intake, alcohol consumption, and smoking.
Current Funding for Bone Mineral Density Testing
The Ontario Health Insurance Program (OHIP) Schedule presently reimburses DXA BMD at the hip and spine. Measurements at both sites are required if feasible. Patients at low risk of accelerated bone loss are limited to one BMD test within any 24-month period, but there are no restrictions on people at high risk. The total fee including the professional and technical components for a test involving 2 or more sites is $106.00 (Cdn).
Method of Review
This review consisted of 2 parts. The first part was an analysis of Ontario administrative data relating to DXA BMD, wrist and hip fractures, and use of antiresorptive drugs in people aged 65 years and older. The Institute for Clinical Evaluative Sciences extracted data from the OHIP claims database, the Canadian Institute for Health Information hospital discharge abstract database, the National Ambulatory Care Reporting System, and the Ontario Drug Benefit database using OHIP and ICD-10 codes. The data was analyzed to examine the trends in DXA BMD use from 1992 to 2005, and to identify areas requiring improvement.
The second part included systematic reviews and analyses of evidence relating to issues identified in the analyses of utilization data. Altogether, 8 reviews and qualitative syntheses were performed, consisting of 28 published systematic reviews and/or meta-analyses, 34 randomized controlled trials, and 63 observational studies.
Findings of Utilization Analysis
Analysis of administrative data showed a 10-fold increase in the number of BMD tests in Ontario between 1993 and 2005.
OHIP claims for BMD tests are presently increasing at a rate of 6 to 7% per year. Approximately 500,000 tests were performed in 2005/06 with an age-adjusted rate of 8,600 tests per 100,000 population.
Women accounted for 90 % of all BMD tests performed in the province.
In 2005/06, there was a 2-fold variation in the rate of DXA BMD tests across local integrated health networks, but a 10-fold variation between the county with the highest rate (Toronto) and that with the lowest rate (Kenora). The analysis also showed that:
With the increased use of BMD, there was a concomitant increase in the use of antiresorptive drugs (as shown in people 65 years and older) and a decrease in the rate of hip fractures in people age 50 years and older.
Repeat BMD made up approximately 41% of all tests. Most of the people (>90%) who had annual BMD tests in a 2-year or 3-year period were coded as being at high risk for osteoporosis.
18% (20,865) of the people who had a repeat BMD within a 24-month period and 34% (98,058) of the people who had one BMD test in a 3-year period were under 65 years, had no fracture in the year, and coded as low-risk.
Only 19% of people age greater than 65 years underwent BMD testing and 41% received osteoporosis treatment during the year following a fracture.
Men accounted for 24% of all hip fractures and 21 % of all wrist fractures, but only 10% of BMD tests. The rates of BMD tests and treatment in men after a fracture were only half of those in women.
In both men and women, the rate of hip and wrist fractures mainly increased after age 65 with the sharpest increase occurring after age 80 years.
Findings of Systematic Review and Analysis
Serial Bone Mineral Density Testing for People Not Receiving Osteoporosis Treatment
A systematic review showed that the mean rate of bone loss in people not receiving osteoporosis treatment (including postmenopausal women) is generally less than 1% per year. Higher rates of bone loss were reported for people with disease conditions or on medications that affect bone metabolism. In order to be considered a genuine biological change, the change in BMD between serial measurements must exceed the least significant change (variability) of the testing, ranging from 2.77% to 8% for precisions ranging from 1% to 3% respectively. Progression in BMD was analyzed, using different rates of baseline BMD values, rates of bone loss, precision, and BMD value for initiating treatment. The analyses showed that serial BMD measurements every 24 months (as per OHIP policy for low-risk individuals) is not necessary for people with no major risk factors for osteoporosis, provided that the baseline BMD is normal (T-score ≥ –1), and the rate of bone loss is less than or equal to 1% per year. The analyses showed that for someone with a normal baseline BMD and a rate of bone loss of less than 1% per year, the change in BMD is not likely to exceed least significant change (even for a 1% precision) in less than 3 years after the baseline test, and is not likely to drop to a BMD level that requires initiation of treatment in less than 16 years after the baseline test.
Serial Bone Mineral Density Testing in People Receiving Osteoporosis Therapy
Seven published meta-analysis of randomized controlled trials (RCTs) and 2 recent RCTs on BMD monitoring during osteoporosis therapy showed that although higher increases in BMD were generally associated with reduced risk of fracture, the change in BMD only explained a small percentage of the fracture risk reduction.
Studies showed that some people with small or no increase in BMD during treatment experienced significant fracture risk reduction, indicating that other factors such as improved bone microarchitecture might have contributed to fracture risk reduction.
There is conflicting evidence relating to the role of BMD testing in improving patient compliance with osteoporosis therapy.
Even though BMD may not be a perfect surrogate for reduction in fracture risk when monitoring responses to osteoporosis therapy, experts advised that it is still the only reliable test available for this purpose.
A systematic review conducted by the Medical Advisory Secretariat showed that the magnitude of increases in BMD during osteoporosis drug therapy varied among medications. Although most of the studies yielded mean percentage increases in BMD from baseline that did not exceed the least significant change for a 2% precision after 1 year of treatment, there were some exceptions.
Bone Mineral Density Testing and Treatment After a Fragility Fracture
A review of 3 published pooled analyses of observational studies and 12 prospective population-based observational studies showed that the presence of any prevalent fracture increases the relative risk for future fractures by approximately 2-fold or more. A review of 10 systematic reviews of RCTs and 3 additional RCTs showed that therapy with antiresorptive drugs significantly reduced the risk of vertebral fractures by 40 to 50% in postmenopausal osteoporotic women and osteoporotic men, and 2 antiresorptive drugs also reduced the risk of nonvertebral fractures by 30 to 50%. Evidence from observational studies in Canada and other jurisdictions suggests that patients who had undergone BMD measurements, particularly if a diagnosis of osteoporosis is made, were more likely to be given pharmacologic bone-sparing therapy. Despite these findings, the rate of BMD investigation and osteoporosis treatment after a fracture remained low (<20%) in Ontario as well as in other jurisdictions.
Bone Mineral Density Testing in Men
There are presently no specific Canadian guidelines for BMD screening in men. A review of the literature suggests that risk factors for fracture and the rate of vertebral deformity are similar for men and women, but the mortality rate after a hip fracture is higher in men compared with women. Two bisphosphonates had been shown to reduce the risk of vertebral and hip fractures in men. However, BMD testing and osteoporosis treatment were proportionately low in Ontario men in general, and particularly after a fracture, even though men accounted for 25% of the hip and wrist fractures. The Ontario data also showed that the rates of wrist fracture and hip fracture in men rose sharply in the 75- to 80-year age group.
Ontario-Based Economic Analysis
The economic analysis focused on analyzing the economic impact of decreasing future hip fractures by increasing the rate of BMD testing in men and women age greater than or equal to 65 years following a hip or wrist fracture. A decision analysis showed the above strategy, especially when enhanced by improved reporting of BMD tests, to be cost-effective, resulting in a cost-effectiveness ratio ranging from $2,285 (Cdn) per fracture avoided (worst-case scenario) to $1,981 (Cdn) per fracture avoided (best-case scenario). A budget impact analysis estimated that shifting utilization of BMD testing from the low risk population to high risk populations within Ontario would result in a saving of $0.85 million to $1.5 million (Cdn) to the health system. The potential net saving was estimated at $1.2 million to $5 million (Cdn) when the downstream cost-avoidance due to prevention of future hip fractures was factored into the analysis.
Other Factors for Consideration
There is a lack of standardization for BMD testing in Ontario. Two different standards are presently being used and experts suggest that variability in results from different facilities may lead to unnecessary testing. There is also no requirement for standardized equipment, procedure or reporting format. The current reimbursement policy for BMD testing encourages serial testing in people at low risk of accelerated bone loss. This review showed that biannual testing is not necessary for all cases. The lack of a database to collect clinical data on BMD testing makes it difficult to evaluate the clinical profiles of patients tested and outcomes of the BMD tests. There are ministry initiatives in progress under the Osteoporosis Program to address the development of a mandatory standardized requisition form for BMD tests to facilitate data collection and clinical decision-making. Work is also underway for developing guidelines for BMD testing in men and in perimenopausal women.
Conclusion
Increased use of BMD in Ontario since 1996 appears to be associated with increased use of antiresorptive medication and a decrease in hip and wrist fractures.
Data suggest that as many as 20% (98,000) of the DXA BMD tests in Ontario in 2005/06 were performed in people aged less than 65 years, with no fracture in the current year, and coded as being at low risk for accelerated bone loss; this is not consistent with current guidelines. Even though some of these people might have been incorrectly coded as low-risk, the number of tests in people truly at low risk could still be substantial.
Approximately 4% (21,000) of the DXA BMD tests in 2005/06 were repeat BMDs in low-risk individuals within a 24-month period. Even though this is in compliance with current OHIP reimbursement policies, evidence showed that biannual serial BMD testing is not necessary in individuals without major risk factors for fractures, provided that the baseline BMD is normal (T-score < –1). In this population, BMD measurements may be repeated in 3 to 5 years after the baseline test to establish the rate of bone loss, and further serial BMD tests may not be necessary for another 7 to 10 years if the rate of bone loss is no more than 1% per year. Precision of the test needs to be considered when interpreting serial BMD results.
Although changes in BMD may not be the perfect surrogate for reduction in fracture risk as a measure of response to osteoporosis treatment, experts advised that it is presently the only reliable test for monitoring response to treatment and to help motivate patients to continue treatment. Patients should not discontinue treatment if there is no increase in BMD after the first year of treatment. Lack of response or bone loss during treatment should prompt the physician to examine whether the patient is taking the medication appropriately.
Men and women who have had a fragility fracture at the hip, spine, wrist or shoulder are at increased risk of having a future fracture, but this population is presently under investigated and under treated. Additional efforts have to be made to communicate to physicians (particularly orthopaedic surgeons and family physicians) and the public about the need for a BMD test after fracture, and for initiating treatment if low BMD is found.
Men had a disproportionately low rate of BMD tests and osteoporosis treatment, especially after a fracture. Evidence and fracture data showed that the risk of hip and wrist fractures in men rises sharply at age 70 years.
Some counties had BMD utilization rates that were only 10% of that of the county with the highest utilization. The reasons for low utilization need to be explored and addressed.
Initiatives such as aligning reimbursement policy with current guidelines, developing specific guidelines for BMD testing in men and perimenopausal women, improving BMD reports to assist in clinical decision making, developing a registry to track BMD tests, improving access to BMD tests in remote/rural counties, establishing mechanisms to alert family physicians of fractures, and educating physicians and the public, will improve the appropriate utilization of BMD tests, and further decrease the rate of fractures in Ontario. Some of these initiatives such as developing guidelines for perimenopausal women and men, and developing a standardized requisition form for BMD testing, are currently in progress under the Ontario Osteoporosis Strategy.
PMCID: PMC3379167  PMID: 23074491
3.  Instrumentation in lumbar fusion improves back pain but not quality of life 2 years after surgery 
Acta Orthopaedica  2013;84(1):7-11.
Background and purpose
Instrumented and non-instrumented methods of fusion have been compared in several studies, but the results are often inconsistent and conflicting. We compared the 2-year results of 3 methods of lumbar fusion when used in degenerative disc disease (DDD), using the Swedish Spine Register (SWESPINE).
Methods
All patients registered in SWESPINE for surgical treatment of DDD between January 1, 2000 and October 1, 2007 were eligible for the study. Patients who had completed the 2-year follow-up were included in the analysis. The outcomes of 3 methods of surgical fusion were assessed.
Results
Of 1,310 patients enrolled, 115 had undergone uninstrumented fusion, 620 instrumented posterolateral fusion, and 575 instrumented interbody fusion. Irrespective of the surgical procedure, quality of life (QoL) improved and back pain diminished. Change in QoL and functional disability and return to work was similar in the 3 groups. Patients who had undergone uninstrumented fusion had more back pain than the patients with instrumented interbody fusion at the 2-year follow-up (p = 0.02), although the difference was only 7 visual analog scale (VAS) units (95% CI: 1–13) on a 100-point scale. Moreover, 83% of the patients with uninstrumented fusion used analgesics at the end of follow-up as compared to 68% of the patients who had undergone surgery with one of the 2 instrumented fusion techniques.
Interpretation
In comparison with instrumented interbody fusion, uninstrumented fusion was associated with higher levels of back pain 2 years after surgery. We found no evidence for differences in QoL between uninstrumented fusion and instrumented interbody fusion.
doi:10.3109/17453674.2013.771300
PMCID: PMC3584606  PMID: 23368746
4.  Pain 5 years after instrumented and non-instrumented posterolateral lumbar spinal fusion 
European Spine Journal  2003;12(4):393-399.
Pain drawings have been used in spine surgery for diagnostic use and psychological evaluation of fusion candidates; they have rarely been used to evaluate pain status after spinal fusion. This study is a 5-year follow-up on a randomised clinical trial assigning patients to posterolateral spinal fusion with or without pedicle screw instrumentation. Patients were mailed a pain drawing and questionnaires including questions regarding work, social status, smoking status, the Dallas Pain Questionnaire (DPQ), and the Low Back Pain Rating Scale (LBPRS). Pain drawings were scored using a visual inspection method and a surface-based point scoring and evaluated for the presence of donor site pain. Pain drawings from 109 patients (87% of the initially included patients), 56 men and 53 women, mean age at follow-up 51 years, were analysed. Fifty-three patients had undergone an instrumented fusion and 56 a non-instrumented fusion. Some presence of low back pain was marked by 79% and leg pain by 69%. Sixty-two percent of the pain drawings were classified as "organic" and 38% as "non-organic". There was no difference between the instrumented and the uninstrumented group. DPQ and LBPRS scores were higher in the non-organic group (P=0.007). Using the point scoring, no difference between the instrumented and the uninstrumented group was seen. The results of the point scoring were found to correlate with the DPQ and LBPRS scores (P=0.001). Working patients (39%) had significantly better scores than the rest. Ten percent of the patients had donor site pain. Twenty percent of spinal fusion patients are totally pain free at 5-year follow-up. Ten percent still experience donor site pain. In general, instrumentation does not affect the amount and localisation of pain 5 years after lumbar spinal fusion surgery. The pain drawing seems to be a valuable tool when following spinal fusion patients, but its use as prognostic marker in connection with fusion surgery needs further investigation.
doi:10.1007/s00586-003-0547-6
PMCID: PMC3467782  PMID: 12756629
Pain drawing; Spinal fusion; Dallas Pain Questionnaire; Low Back Pain Rating Scale; Donor site pain; Instrumentation; Randomised clinical trial
5.  The Effects of Ketorolac Injected via Patient Controlled Analgesia Postoperatively on Spinal Fusion 
Yonsei Medical Journal  2005;46(2):245-251.
Lumbar spinal fusions have been performed for spinal stability, pain relief and improved function in spinal stenosis, scoliosis, spinal fractures, infectious conditions and other lumbar spinal problems. The success of lumbar spinal fusion depends on multifactors, such as types of bone graft materials, levels and numbers of fusion, spinal instrumentation, electrical stimulation, smoking and some drugs such as nonsteroidal anti-inflammatory drugs (NSAIDs). From January 2000 to December 2001, 88 consecutive patients, who were diagnosed with spinal stenosis or spondylolisthesis, were retrospectively enrolled in this study. One surgeon performed all 88 posterolateral spinal fusions with instrumentation and autoiliac bone graft. The patients were divided into two groups. The first group (n=30) was infused with ketorolac and fentanyl intravenously via patient controlled analgesia (PCA) postoperatively and the second group (n=58) was infused only with fentanyl. The spinal fusion rates and clinical outcomes of the two groups were compared. The incidence of incomplete union or nonunion was much higher in the ketorolac group, and the relative risk was approximately 6 times higher than control group (odds ratio: 5.64). The clinical outcomes, which were checked at least 1 year after surgery, showed strong correlations with the spinal fusion status. The control group (93.1%) showed significantly better clinical results than the ketorolac group (77.6%). Smoking had no effect on the spinal fusion outcome in this study. Even though the use of ketorolac after spinal fusion can reduce the need for morphine, thereby decreasing morphine related complications, ketorolac used via PCA at the immediate postoperative state inhibits spinal fusion resulting in a poorer clinical outcome. Therefore, NSAIDs such as ketorolac, should be avoided after posterolateral spinal fusion.
doi:10.3349/ymj.2005.46.2.245
PMCID: PMC2823021  PMID: 15861498
Lumbar spine; spinal fusion; ketorolac
6.  Lumbar Interbody Fusion Outcomes in Degenerative Lumbar Disease : Comparison of Results between Patients Over and Under 65 Years of Age 
Objective
To evaluate the clinical and radiological outcomes of lumbar interbody fusion and its correlation with various factors (e.g., age, comorbidities, fusion level, bone quality) in patients over and under 65 years of age who underwent lumbar fusion surgery for degenerative lumbar disease.
Methods
One-hundred-thirty-three patients with lumbar degenerative disease underwent lumbar fusion surgery between June 2006 and June 2007 and were followed for more than one year. Forty-eight (36.1%) were older than 65 years of age (group A) and 85 (63.9%) were under 65 years of age (group B). Diagnosis, comorbidities, length of hospital stay, and perioperative complications were recorded. The analysis of clinical outcomes was based on the visual analogue scale (VAS). Radiological results were evaluated using plain radiographs. Clinical outcomes, radiological outcomes, length of hospital stay, and complication rates were analyzed in relation to lumbar fusion level, the number of comorbidities, bone mineral density (BMD), and age.
Results
The mean age of the patients was 61.2 years (range, 33-86 years) and the mean BMD was -2.2 (range, -4.8 to -2.8). The mean length of hospital stay was 15.0 days (range, 5-60 days) and the mean follow-up was 23.0 months (range, 18-30 months). Eighty-five (64.0%) patients had more than one preoperative comorbidities. Perioperative complications occurred in 27 of 133 patients (20.3%). The incidence of overall complication was 22.9% in group A, and 18.8% in group B but there was no statistical difference between the two groups. The mean VAS scores for the back and leg were significantly decreased in both groups (p < 0.05), and bony fusion was achieved in 125 of 133 patients (94.0%). There was no significant difference in bony union rates between groups A and B (91.7% in group A vs. 95.3% in group B, p = 0.398). In group A, perioperative complications were more common with the increase in fusion level (p = 0.027). Perioperative complications in both groups A (p = 0.035) and B (p = 0.044) increased with an increasing number of comorbidities.
Conclusion
Elderly patients with comorbidities are at a high risk for complications and adverse outcomes after lumbar spine surgery. In our study, clinical outcomes, fusion rates, and perioperative complication rates in older patients were comparable with those in younger populations. The number of comorbidities and the extent of fusion level were significant factors in predicting the occurrence of postoperative complications. However, proper perioperative general supportive care with a thorough fusion strategy during the operation could improve the overall postoperative outcomes in lumbar fusion surgery for elderly patients.
doi:10.3340/jkns.2010.48.5.412
PMCID: PMC3030080  PMID: 21286477
Elderly patients; Lumbar interbody fusion; Comorbidities; Complications
7.  The First Clinical Trial of Beta-Calcium Pyrophosphate as a Novel Bone Graft Extender in Instrumented Posterolateral Lumbar Fusion 
Clinics in Orthopedic Surgery  2011;3(3):238-244.
Background
Porous β-calcium pyrophosphate (β-CPP) was developed to improve the fusion success of posterolateral lumbar fusion (PLF). The possibility of accomplishing PLF using a mixture of porous β-CPP and iliac bone was studied. This paper reports the radiologic results of PLF using the β-CPP plus autograft for lumbar degenerative disease as a bone graft extender.
Methods
A prospective, case-matched, radiographic study evaluating the results of short segment lumbar fusion using a β-CPP plus autograft was performed to compare the efficacy of β-CPP plus autograft with that of an autograft alone for short segment lumbar fusion. Thirty one consecutive patients (46 levels) underwent posterolateral fusion with pedicle screw fixation and additional posterior lumbar interbody fusion. In all patients, 3 mL of β-CPP plus 3 mL of autogenous bone graft was placed randomly in one side of a posterolateral gutter, and 6 mL of autogenous iliac bone graft was placed on the other. The fusion rates, volumes of fusion masses, and bone absorption percentage were evaluated postoperatively using simple radiographs and 3 dimensional computed tomography (3D-CT) scans.
Results
The control sides treated with an autograft showed significantly better Lenke scores than the study sides treated with β-CPP at 3 and 6 months postoperatively, but there was no difference between the two sides at 12 months. The fusion rates (confirmed by 3D-CT) were 87.0% in the β-CPP group and 89.1% in the autograft group, which were not significantly different. The fusion mass volumes and bone absorption percentage at 12 months postoperatively were 2.49 mL (58.4%) and 1.89 mL (69.5%) for the β-CPP and autograft groups, respectively, and mean fusion mass volume was significantly higher in the β-CPP group.
Conclusions
β-CPP combined with an autograft is as effective as autologous bone for grafting during instrumented posterolateral spinal fusion. These findings suggest that β-CPP bone chips can be used as a novel bone graft extender for short-segment posterolateral spinal fusion.
doi:10.4055/cios.2011.3.3.238
PMCID: PMC3162205  PMID: 21909472
Beta-calcium pyrophosphate; Bone graft extender; Fusion rate; Lumbar posterolateral fusion; Prospective consecutive study
8.  Bone Metabolism Disorders in Patients with Spinal Cord Injuries 
In Italy, 60–70 thousand people are affected by spinal cord lesions, which have an incidence of 20/25 new cases per million per year and a male:female ratio of 4:1. The age group most affected is 10–40 years. In 65% of cases the origin of the lesion is traumatic. According to the ASIA (American Spinal Injury Association) Impairment Scale (AIS), the lesion is defined complete or incomplete, depending on whether or not partial conservation of sensory and/or motor functions is found below the level of the lesion in the first 24 hours following the trauma. Patients with spinal injuries show alterations of phosphocalcic metabolism, with osteoporosis, neurogenic para-osteo-arthropathy and renal calculi. Even though post-lesion osteoporosis is traditionally considered secondary to reduced loading, it has characteristics different from those of primary osteoporosis and osteoporosis caused by endocrine disorders or by simple disuse. Indeed, there is usually no significant demineralisation of the bone segments above the level of the neurological lesion and the site and entity of the bone resorption are influenced by factors such as age, sex, muscle spasticity, but above all by lesion site, lesion severity, and post-lesion period.
Osteocytes (the mechanosensors in bone tissue), via extracellular and intracellular signal transmitters, transmit mechanical load signals to the osteoblasts, stimulating bone formation and inhibiting bone resorption by the osteoclasts.
A spinal injury results in prolonged limitation of both the loading and the movement of the lower limbs; this leads to marked muscle atrophy, inhibition of the osteoblasts and activation of the osteoclasts, and an inevitable loss of bone tissue. The increase in bone resorption following a spinal injury is reflected in increased urinary excretion of hydroxyproline, pyridinoline, deoxypyridinoline and type I collagen C-telopeptide. Significantly increased expression of RANKL mRNA and protein in cultures of osteoblast-like cells from spinal injured rats has also been observed, while OPG expression is significantly reduced and osteoclastogenesis increased. Spinal lesions are also associated with supplementary production, in the bone marrow, of cytokines like IL-6, potential mediators of bone mass loss.
Recent studies suggest that bone remodelling is also influenced by nervous signals: after denervation, due to a spinal lesion, there is a marked reduction in innervation density and in neuropeptides, such as VIP, PACAP, NPY, SP, CGRP, noradrenaline, glutamate and serotonin, mainly in bone segments below the level of the lesion; this upsets the balance between bone resorption and formation. In addition to its direct role in bone metabolism, denervation can induce alterations of vascular regulation: indeed, a complete spinal injury causes alterations of the sympathetic innervation with possible opening of intraosseous venous shunts that, leading to venous and capillary stasis with increase in local pressure, could favour the formation of osteoclasts, accelerating the process of bone resorption; osteopenia is indeed predominant in the meta-epiphyseal areas of long bones, which are highly vascularised.
In the first months following the injury, the demineralisation generally affects mainly the distal femur and proximal tibia, segments rich in trabecular bone, while the femoral and tibial diaphyses, which are rich in cortical bone, are relatively spared.
Paradoxically, in the lumbar spine, in which the trabecular component is prevalent, DXA scans do not reveal significant reductions in bone mineral density, independently of the lesion level or duration. This may be because the spinal column exerts an ongoing bodyweight-supporting action during wheelchair use. Nevertheless, on DXA studies, BMD at lumbar level can sometimes erroneously appear increased on account of the presence of osteophytes due to neuropathic spondylopathy. To overcome the limits of this approach, the most recent studies have used densitometric methods such as QCT (quantitative computerised tomography) to assess the density of trabecular and cortical bone in the distal radius and tibia.
Up to a third of spinal cord injured patients are liable to sustain fragility fractures. Although they are asymptomatic, these fractures can cause complications, such as abnormal bone callus formation, bedsores and increased spasticity, all factors that can further deteriorate the patient’s already precarious state of health.
Reduction of fracture risk through an appropriate treatment of osteoporosis after spinal cord injury is particularly important for the prognosis and quality of life of these patients. In this context, the application of diagnostic protocols, both haematological and instrumental, for the monitoring and therapeutic control of bone demineralisation over time could be an effective help.
PMCID: PMC3213781
9.  Effect of zoledronic acid in an L6–L7 rabbit spine fusion model 
European Spine Journal  2006;16(4):557-562.
Previous studies have shown that zoledronic acid administration can increase mineral content and strength in distraction osteogenesis. Of the few studies that have examined the use of bisphosphonates in spinal arthrodesis, none have assessed the effect of single dose treatment. The objective of this study was to evaluate the feasibility of enhancing spinal fusion rate using single dose zoledronic acid (ZA) to increase fusion-mass size and mineral density. Forty-eight New Zealand white rabbits underwent an L6–L7 intertransverse process fusion. The L6–L7 model is more challenging than the more commonly used level of L5–L6. Animals were randomly allocated to one of three groups, one received iliac crest bone graft alone, one group received iliac crest bone graft with locally administered zoledronic acid, 20 μg, and one group received iliac crest bone graft with a single dose of systemically administered zoledronic acid, 0.1 mg/kg. ZA doses were administered at the time of surgery. Twenty-four rabbits were culled at 6 weeks and 24 rabbits were culled at 12 weeks. Success of spinal fusion was determined by manual palpation. Specimens were evaluated radiographically, underwent quantitative computerised tomography analysis and were tested biomechanically in flexion and extension. In the six-week group, only five of the 24 spines fused with no noticeable trend with respect to treatment. In the 12-week group there was a trend toward increased fusion in the systemically administered ZA group (63%) versus the other two groups (25%) but was not statistically significant (p = 0.15). Radiographically, the local ZA treatment group showed a delay in remodelling with the presence of unremodelled bone chips. The 12-week systemic ZA group exhibited an 86% increase in BMC, a 31% increase in vBMD and a 41% increase in the volume of the fusion-mass (p < 0.05). The 12-week local ZA group also showed significant increases in BMC (69%), vBMD (31%) and total fusion-mass volume (29%) (p < 0.05). Biomechanical testing showed that the range of motion in flexion decreased to 4.5 (±2.5) degrees and 4.8 (±4.7) degrees for the local and systemic groups respectively compared to 9.6 (±4.9) degrees for the control group (p < 0.05). This study has shown that zoledronic acid increased fusion-mass size and bone mineral content. Systemic ZA led to an increased fusion rate; however the fusion rate remained below 100%. We suggest that bisphosphonate treatment may require an anabolic conjunctive therapy to ensure enhanced successful fusion.
doi:10.1007/s00586-006-0212-y
PMCID: PMC2229826  PMID: 16967298
Posterolateral fusion; Rabbit; Zoledronic acid; Animal model; Pseudarthrosis
10.  Efficacy of Alendronate in the Management of Fragility Fractures 
Osteoporosis, particularly common in post-menopausal women, is a disease characterised by altered bone turnover, progressive loss of bone mass, deterioration of bone architecture and increased fracture risk. Precisely in order to prevent fractures, it is useful to administer osteotropic drugs that act on the altered bone metabolism in order to slow down bone resorption.
Biphosphonates are the drugs most commonly prescribed to prevent and treat post-menopausal osteoporosis and they have been shown to exert important effects on bone tissue, preventing excessive weakening, preferentially localising to sites of bone resorption, and provoking osteoclast inhibition without any direct effect on new bone formation. This results in an uncoupling of anabolic and catabolic processes that translates into increased bone mass.
Alendronate, a powerful inhibitor of bone resorption that belongs to the biphosphonate class of drugs, was shown, in a heterogeneous cohort of patients, to produce significant reductions in markers of bone resorption and considerable, dose-related increases in bone mineral density (BMD). Alendronate, at a mimumum dose of 10 mg/day, has been shown to increase BMD values by 7.5% in the lumbar spine after two-three years of treatment, by 5.6% at the neck of the femur after three-four years of treatment, and by 2.1% at forearm level after treatment lasting two-four years; instead, at 5 mg/day it was found to increase BMD levels by 5.8%, 4.6% and 1.8%, respectively. Furthermore, the drug has been widely shown to be effective in preventing both vertebral and non-vertebral fractures (including hip fractures) and was also found to be effective in reducing the incidence of vertebral fractures in corticosteroid-induced osteoporosis. These effects have been demonstrated in numerous studies, which have shown that drug is able to significantly reduce the risk of vertebral, non-vertebral and hip fractures (level IA evidence) compared with placebo, and to conserve bone mass (level IA evidence), with an increase in BMD within three months of the start of treatment, both at spinal and at hip level, and even in women and men taking corticosteroids. These effects were confirmed in studies with follow ups as long as ten years, providing evidence of the long-term efficacy of the drug and its high level of tolerability throughout the duration of treatment.
Weekly dosing (70 mg) of alendronate can increase compliance in poorly collaborating patients or patients with numerous comorbidities. With this dosing regimen, the drug was also shown to be effective in improving screw fixation in cancellous bone in a group of elderly patients with confirmed poor bone quality.
PMCID: PMC3213791
11.  Correlative radiological, self-assessment and clinical analysis of evolution in instrumented dorsal and lateral fusion for degenerative lumbar spine disease. Autograft versus coralline hydroxyapatite 
European Spine Journal  2005;14(7):630-638.
This prospective longitudinal randomized clinical and radiological study compared the evolution of instrumented posterolateral lumbar and lumbosacral fusion using either coralline hydroxyapatite (CH), or iliac bone graft (IBG) or both in three comparable groups, A, B and C, which included 19, 18 and 20 patients, respectively, who suffered from symptomatic degenerative lumbar spinal stenosis and underwent decompression and fusion. The patients were divided randomly according to the graft used and the side that it was applied. The spines of group A received autologous IBG bilaterally; group B, IBG on the left side and hydroxyapatite mixed with local bone and bone marrow on the right side; group C, hydroxyapatite mixed with local bone and bone marrow bilaterally. The age of the patients in the groups A, B and C was 61±11 years, 64±8 years and 58±8 years, respectively. The SF-36, Oswestry Disability Index (ODI), and Roland-Morris (R-M) surveys were used for subjective evaluation of the result of the surgery and the Visual Analogue Scale (VAS) for pain severity. Plain roentgenograms including anteroposterior, lateral and oblique views, and lateral plus frontal bending views of the instrumented spine and CT scan were used to evaluate the evolution of the posterolateral fusion in all groups and sides. Two independent senior orthopaedic radiologists were asked to evaluate first the evolution of the dorsolateral bony fusion 3–48 months postoperatively with the Christiansen’s radiologic method, and secondly the hydroxyapatite resorption course in the spines of groups B and C. The diagnosis of solid spinal fusion was definitively confirmed with the addition of the bending views, CT scans and self-assessment scores. The intraobserver and interobserver agreement (r) for radiological fusion was 0.71 and 0.69, respectively, and 0.83 and 0.76 for evaluation of CH resorption. T12−S1 lordosis and segmental angulation did not change postoperatively. There was no radiological evidence for non-union on the plain roentgenograms and CT scans. Radiological fusion was achieved 1 year postoperatively and was observed in all groups and vertebral segments. Six months postoperatively there was an obvious resorption of hydroxyapatite granules at the intertransverse intersegmental spaces in the right side of the spines of group B and both sides of group C. The resorption of hydroxyapatite was completed 1 year postoperatively. Bone bridging started in the third month postoperatively in all instrumented spines and all levels posteriorly as well as between the transverse processes in the spines of the group A and on the left side of the spines of group B where IBG was applied. SF-36, ODI, and R-M score improved postoperatively in a similar way in all groups. There was one pedicle screw breakage at the lowermost instrumented level in group A and two in group C without radiologically visible pseudarthrosis, which were considered as having non-union. Operative time and blood loss were less in the patients of group C, while donor site complaints were observed in the patients of the groups A and B only. This study showed that autologous IBG remains the “gold standard” for achieving solid posterior instrumented lumbar fusion, to which each new graft should be compared. The incorporation of coralline hydroxyapatite mixed with local bone and bone marrow needs adequate bleeding bone surface. Subsequently, hydroxyapatite was proven in this series to not be appropriate for intertransverse posterolateral fusion, because the host bone in this area is little. However, the use of hydroxyapatite over the decorticated laminae that represents a wide host area was followed by solid dorsal fusion within the expected time.
doi:10.1007/s00586-004-0855-5
PMCID: PMC3489222  PMID: 15789231
Coralline hydroxyapatite; Lumbar spinal stenosis; Instrumented fusion
12.  Instrumented fusion of thoracolumbar fracture with type I mineralized collagen matrix combined with autogenous bone marrow as a bone graft substitute: a four-case report 
European Spine Journal  2006;15(Suppl 17):630-635.
In order to avoid the morbidity from autogenous bone harvesting, bone graft substitutes are being used more frequently in spinal surgery. There is indirect radiological evidence that bone graft substitutes are efficacious in humans. The purpose of this four-case study was to visually, manually, and histologically assess the quality of a fusion mass produced by a collagen hydroxyapatite scaffold impregnated with autologous bone marrow aspirate for posterolateral fusion. Four patients sustained an acute thoracolumbar fracture and were treated by short posterior segment fusion using the AO fixateur interne. Autologous bone marrow (iliac crest) impregnated hydroxyapatite-collagen scaffold was laid on the decorticated posterior elements. Routine implant removal was performed after a mean of 15.3 months (12–20). During this second surgery, fusion mass was assessed visually and manually. A bone biopsy was sent for histological analysis of all four cases. Fusion was confirmed in all four patients intraoperatively and sagittal stress testing confirmed mechanical adequacy of the fusion mass. Three out of the four (cases 2–4) had their implants removed between 12 and 15 months after the index surgery. All their histological cuts showed evidence of newly formed bone and presence of active membranous and/or enchondral ossification foci. The last patient (case 1) underwent implant removal at 20 months and his histological cuts showed mature bone, but no active ossification foci. This four-case report suggests that the fusion mass produced by a mineralized collagen matrix graft soaked in aspirated bone marrow is histologically and mechanically adequate in a thoracolumbar fracture model. A larger patient series and/or randomized controlled studies are warranted to confirm these initial results.
doi:10.1007/s00586-006-0162-4
PMCID: PMC1602197  PMID: 16865378
Thoracolumbar spine; Fracture; Fusion; Bone graft substitute
13.  Instrumented fusion of thoracolumbar fracture with type I mineralized collagen matrix combined with autogenous bone marrow as a bone graft substitute: a four-case report 
European Spine Journal  2006;15(Suppl 5):630-635.
In order to avoid the morbidity from autogenous bone harvesting, bone graft substitutes are being used more frequently in spinal surgery. There is indirect radiological evidence that bone graft substitutes are efficacious in humans. The purpose of this four-case study was to visually, manually, and histologically assess the quality of a fusion mass produced by a collagen hydroxyapatite scaffold impregnated with autologous bone marrow aspirate for posterolateral fusion. Four patients sustained an acute thoracolumbar fracture and were treated by short posterior segment fusion using the AO fixateur interne. Autologous bone marrow (iliac crest) impregnated hydroxyapatite-collagen scaffold was laid on the decorticated posterior elements. Routine implant removal was performed after a mean of 15.3 months (12–20). During this second surgery, fusion mass was assessed visually and manually. A bone biopsy was sent for histological analysis of all four cases. Fusion was confirmed in all four patients intraoperatively and sagittal stress testing confirmed mechanical adequacy of the fusion mass. Three out of the four (cases 2–4) had their implants removed between 12 and 15 months after the index surgery. All their histological cuts showed evidence of newly formed bone and presence of active membranous and/or enchondral ossification foci. The last patient (case 1) underwent implant removal at 20 months and his histological cuts showed mature bone, but no active ossification foci. This four-case report suggests that the fusion mass produced by a mineralized collagen matrix graft soaked in aspirated bone marrow is histologically and mechanically adequate in a thoracolumbar fracture model. A larger patient series and/or randomized controlled studies are warranted to confirm these initial results.
doi:10.1007/s00586-006-0162-4
PMCID: PMC1602197  PMID: 16865378
Thoracolumbar spine; Fracture; Fusion; Bone graft substitute
14.  Direct repair for treatment of symptomatic spondylolysis and low-grade isthmic spondylolisthesis in young patients: no benefit in comparison to segmental fusion after a mean follow-up of 14.8 years 
European Spine Journal  2006;15(10):1437-1447.
The aim of the present study was to assess the long-term clinical, functional, and radiographic outcome of direct repair of spondylolysis using cerclage wire fixation according to Scott in young patients with symptomatic spondylolysis or low-grade isthmic spondylolisthesis as compared to the outcome after uninstrumented posterolateral in situ fusion. Twenty-five out of 28 patients of the direct repair group (89%) and 23 out of 28 of the fusion group (82%) were available for follow-up examination. The assessment by independent observers included a structured interview (Oswestry questionnaire [ODI], visual analogue scale, SRS questionnaire), a clinical examination, functional testing, plain radiography, and MRI. The groups were comparable as to the mean age at operation (18.2 vs. 16.2 years.), the follow-up time (14.8 vs. 15.0 years), and the amount of preoperative slip (7.2 vs. 13.1%). The mean ODI and SRS total scores were significantly better in the fusion group (4.3 [0–16] and 96 [57–117]) as compared to the direct repair group (11.4[0–52] and 87[53–107]; P=0.02 and P=0.011, respectively). In functional testing, both groups reached normal values for abdominal and back muscle strength. The lumbar spine flexion and extension ROM was decreased in both groups showing no statistical difference between the groups. Significant progressive narrowing of the olisthetic disc was detected on the plain radiographs after direct repair. On the flexion-extension radiographs, in the direct repair group, the mobility in the lytic/olisthetic segment was decreased in comparison to normal values from the literature. The mobility at the level above the operated segment was decreased in the direct repair group as compared to the fusion group (P=0.057). On T2-weighted MR images in the direct repair group, the signal intensity of the disc below the affected vertebra was decreased in 17/23 (74%) patients. There was no difference between the groups in the nucleus signal intensity of the adjacent disc above the operated segment. No association between the disc degeneration on MRI and the outcome of the patients could be established. In the direct repair group the following complications were seen: transient nerve root irritation (2), superficial infection (1), UTI (1); in the fusion group the complications were: subcutaneous seroma (2) and UTI (1). There were six re-operations, cerclage removal(4), conversion into segmental fusion(2) in the direct repair group, and one re-operation, instrumented respondylodesis, in the fusion group. In conclusion, the results of direct repair of the spondylolysis using cerclage wire fixation according to Scott were very satisfactory in 76% of the patients after a mean follow-up of 14.8 years. After direct repair, the ODI deteriorated with time leading to a clinically moderate but statistically significant difference in favour of segmental fusion. Lumbar spine mobility was decreased after direct repair. Secondary segmental instability above the spinal fusion was not detected. The procedure does not seem to be capable of preventing the olisthetic disc from degeneration. The theoretical benefits of direct repair could not be proven.
doi:10.1007/s00586-006-0072-5
PMCID: PMC3241827  PMID: 16463195
Spondylolysis; Isthmic spondylolisthesis; Operative treatment; Direct repair; Posterolateral fusion; Comparative study
15.  Bone Mineral Density as a Predictor of Atherosclerosis and Arterial Wall Stiffness in Obese African-American Women 
Cardiorenal Medicine  2012;2(4):328-334.
Bone demineralization is associated with higher cardiovascular event rates, possibly due to vascular calcification and accelerated atherosclerosis. African-Americans have less bone loss and less calcium content within atherosclerotic plaques. However, whether loss of bone mass is related to atherosclerosis has not been examined in African-Americans. The objective of this study was to evaluate possible associations between bone mineral density (BMD), carotid intimal-medial thickness (CIMT), and arterial stiffness. We studied 100 obese African-American women (BMI: 26.6 ± 6.2; age: 63 ± 14 years) referred for BMD estimation by dual-energy X-ray absorptiometry scan. BMD (g/cm2) was obtained at the lumbar spine (L1–L4), femoral neck, and total hip. Arterial stiffness was evaluated by the heart rate-corrected augmentation index (AI@75) and pulse wave velocity (PWV) using applanation tonometry. CIMT was measured by vascular ultrasound. Mean CIMT, AI@75, and PWV were 0.72 ± 0.14 mm, 28.8 ± 9.0%, and 8.9 ± 1.6 m/s, respectively. Mean BMD values at the lumbar spine, femoral neck, and hip were 0.96 ± 0.19, 0.80 ± 0.16, and 0.91 ± 0.17 g/cm2. Older subjects had higher CIMT (r = 0.61, p < 0.001) and AI@75 (r = 0.42, p < 0.001). There was a significant correlation between AI@75 and CIMT (r = 0.45, p < 0.001). BMD was negatively correlated with AI@75 (lumbar: r = −0.22, p = 0.03; femoral neck: r = −0.24, p = 0.01; hip: r = −0.21, p = 0.03). BMD was unrelated to CIMT (lumbar: r = −0.09, p = 0.42; femoral neck: r = −0.15, p = 0.17; hip: r = −0.13, p = 0.23). On multivariate analysis, age (p < 0.001), hypertension (p = 0.02), and lumbar BMD (p = 0.01, R2 = 0.30) were independent predictors of increased AI@75 after adjusting for age, height, and cardiovascular risk factors. These findings were unchanged upon substitution of femoral neck BMD (p = 0.05, R2 = 0.28) into the model. There was a trend with hip BMD (p = 0.06, R2 = 0.28) in the regression model. Age-matched comparison between normal BMD (n = 25) and osteoporotic patients (n = 34) demonstrated a significant difference in AI@75 (26.6 ± 8.9 vs. 31.6 ± 9.1%, p = 0.04). In summary, women with lower BMD had increased arterial stiffness. There was no relationship between BMD and atherosclerosis. In conclusion, age, hypertension, and BMD are independent predictors of higher arterial stiffness. Vascular changes are related to bone mineral loss, suggesting lower BMD may increase cardiovascular risk in African-Americans.
doi:10.1159/000345461
PMCID: PMC3551407  PMID: 23381741
Bone mineral density; Osteoporosis; Atherosclerosis; Wave reflection; Aortic stiffness
16.  Risk factors for adjacent segment disease after lumbar fusion 
European Spine Journal  2009;18(11):1637-1643.
The incidence of adjacent segment problems after lumbar fusion has been found to vary, and risk factors for these problems have not been precisely verified, especially based on structural changes determined by magnetic resonance imaging. The purpose of this retrospective clinical study was to describe the incidence and clinical features of adjacent segment disease (ASD) after lumbar fusion and to determine its risk factors. We assessed the incidence of ASD in patients who underwent lumbar or lumbosacral fusions for degenerative conditions between August 1995 and March 2006 with at least a 1-year follow-up. Patients less than 35 years of age at the index spinal fusion, patients with uninstrumented fusion, and patients who had not achieved successful union were excluded. Of the 1069 patients who underwent fusions, 28 (2.62%) needed secondary operations because of ASD and were included in this study. In order to identify the risk factors, we matched a disease group and a control group. The disease group consisted of 26 of the 28 patients with ASD, excluding the 2 patients for whom we did not have initial MRI data. Each patient in the disease group was matched by age, sex, fusion level and follow-up period with a control patient. The assumed risk factors included disc and facet degeneration, instability, listhesis, rotational deformity, and disc wedging. The mean age of the 28 patients with ASD requiring surgical treatment was 58.4 years, which did not differ significantly from that of the population in which ASD did not develop (58.2 years, p = 0.894). Of the 21 patients who underwent floating fusion, only 1 developed distal ASD. Facet degeneration was a significant risk factor (p < 0.01) on logistic regression analysis. The incidence of distal ASD was much lower than that of proximal ASD. Pre-existing facet degeneration may be associated with a high risk of adjacent segment problems following lumbar fusion procedures.
doi:10.1007/s00586-009-1060-3
PMCID: PMC2899393  PMID: 19533182
Adjacent segment; Degeneration; Lumbar fusion; Risk factor
17.  Degenerative Spondylolisthesis Is Associated with Low Spinal Bone Density: A Comparative Study between Spinal Stenosis and Degenerative Spondylolisthesis 
BioMed Research International  2013;2013:123847.
Spinal stenosis and degenerative spondylolisthesis share many symptoms and the same treatment, but their causes remain unclear. Bone mineral density has been suggested to play a role. The aim of this study was to investigate differences in spinal bone density between spinal stenosis and degenerative spondylolisthesis patients. 81 patients older than 60 years, who underwent DXA-scanning of their lumbar spine one year after a lumbar spinal fusion procedure, were included. Radiographs were assessed for disc height, vertebral wedging, and osteophytosis. Pain was assessed using the Low Back Pain Rating Scale pain index. T-score of the lumbar spine was significantly lower among degenerative spondylolisthesis patients compared with spinal stenosis patients (−1.52 versus −0.52, P = 0.04). Thirty-nine percent of degenerative spondylolisthesis patients were classified as osteoporotic and further 30% osteopenic compared to only 9% of spinal stenosis patients being osteoporotic and 30% osteopenic (P = 0.01). Pain levels tended to increase with poorer bone status (P = 0.06). Patients treated surgically for symptomatic degenerative spondylolisthesis have much lower bone mass than patients of similar age treated surgically for spinal stenosis. Low BMD might play a role in the development of the degenerative spondylolisthesis, further studies are needed to clarify this.
doi:10.1155/2013/123847
PMCID: PMC3760191  PMID: 24024179
18.  Anterior lumbar interbody fusion: Does stable anterior fixation matter? 
European Spine Journal  2003;12(4):386-392.
The purpose of this study was to compare the outcome of anterior lumbar interbody fusion without instrumentation (uninstrumented ALIF) against that with stable anterior cage fixation using Hartshill horseshoe instrumentation (ALIF-HH) for similar severity of disc disease. Between April 1994 and June 1998 the senior author N.R.B. performed 29 instrumented ALIF procedures with a Hartshill horseshoe cage (ALIF-HH). Between 1990 and 1998, the other senior author (J.M.H.), together with another senior consultant orthopaedic surgeon, performed 27 noninstrumented ALIF procedures using corticocancellous iliac crest autograft. All the patients in both groups had single-level fusion. An independent assessor (S.M.) performed the entire review. The mean follow-up was 4.7 years (2.3–7.9 years) in the uninstrumented ALIF group and 3.0 years (2.1–4.4 years) in the ALIF-HH group. There was subsidence of graft in four patients in the uninstrumented ALIF group. It is reasonable to assume that there was no pseudarthrosis in the ALIF-HH group. This difference was statistically significant (two-sided P-value =0.0425). On subjective score assessment, there was a satisfactory outcome (score≤30) of 87.5% (21 patients) in the uninstrumented ALIF group and 85.2% (23 patients) in the ALIF-HH group (P>0.05). On classification by the Oswestry Index into four categories, we found no difference in outcome between the two groups: 83.3% (n=20) had a satisfactory outcome (defined as Excellent or Better) with ALIF and 77.8% (n=21) had a satisfactory outcome with ALIF-HH using the Oswestry Disability Index for post-operative assessment (P>0.05). The results of this study indicate that the Hartshill horseshoe cage does improve the fusion rate, but does not affect clinical outcome.
doi:10.1007/s00586-003-0543-x
PMCID: PMC3467789  PMID: 12768380
Hartshill horseshoe; Anterior lumbar fusion; Cage
19.  Recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) in posterolateral lumbar spine fusion: complications in the elderly 
Study design
Retrospective cohort study of 1430 patients undergoing lumbar spinal fusion from 2002 - 2009. Objective: The goal of this study was to compare and evaluate the number of complications requiring reoperation in elderly versus younger patients.
Summary of background data
rhBMP-2 has been utilized off label for instrumented lumbar posterolateral fusions for many years. Many series have demonstrated predictable healing rates and reoperations. Varying complication rates in elderly patients have been reported.
Materials and methods
All patients undergoing instrumented lumbar posterolateral fusion of ≤ 3 levels consenting to utilization of rhBMP-2 were retrospectively evaluated. Patient demographics, body mass index, comorbidities, number of levels, associated interbody fusion, and types of bone void filler were analyzed. The age of patients were divided into less than 65 and greater than or equal to 65 years. Complications related to the performed procedure were recorded.
Results
After exclusions, 482 consecutive patients were evaluated with 42.1% males and 57.9% females. Average age was 62 years with 250 (51.9%) < 65 and 232 (48.1%) ≥ 65 years. Patients ≥ 65 years of age stayed longer (5.0 days) in the hospital than younger patients (4.5 days) (p=0.005).
Complications requiring reoperation were: acute seroma formation requiring decompression 15/482, 3.1%, bone overgrowth 4/482, 0.8%, infection requiring debridement 11/482, 2.3%, and revision fusion for symptomatic nonunion 18/482, 3.7%. No significant differences in complications were diagnosed between the two age groups. Statistical differences were noted between the age groups for medical comorbidities and surgical procedures. Patients older than 65 years underwent longer fusions (2.1 versus 1.7 levels, p=0.001).
Discussion
Despite being older and having more comorbidities, elderly patients have similar complication and reoperation rates compared to younger healthier patients undergoing instrumented lumbar decompression fusions with rhBMP-2.
doi:10.1186/1749-799X-8-1
PMCID: PMC3621610  PMID: 23317417
20.  Evaluation of hydroxyapatite and beta-tricalcium phosphate mixed with bone marrow aspirate as a bone graft substitute for posterolateral spinal fusion 
Indian Journal of Orthopaedics  2009;43(3):234-239.
Background:
Autologous cancellous bone is the most effective biological graft material. However, harvest of autologous bone is associated with significant morbidity. Since porous hydroxyapatite and beta-tricalcium phosphate are biodegradable materials and can be replaced by bone tissue, but it lacks osteogenic property. We conducted a study to assess their use as a scaffold and combine them with bone marrow aspirate for bone regeneration using its osteogenic property for posterolateral spinal fusion on one side and autologous bone graft on the other side and compare them radiologically in terms of graft incorporation and fusion.
Materials and Methods:
Thirty patients with unstable dorsal and lumbar spinal injuries who needed posterior stabilization and fusion were evaluated in this prospective study from October 2005 to March 2008. The posterior stabilization was done using pedicle screw and rod assembly, and fusion was done using hydroxyapatite and beta-tricalcium phosphate mixed with bone marrow aspirate as a bone graft substitute over one side of spine and autologous bone graft obtained from iliac crest over other side of spine. The patients were followed up to a minimum of 12 months. Serial radiographs were done at an interval of 3, 6, and 12 months and CT scan was done at one year follow-up. Graft incorporation and fusion were assessed at each follow-up. The study was subjected to statistical analysis using chi-square and kappa test to assess graft incorporation and fusion.
Results:
At the end of the study, radiological graft incorporation and fusion was evident in all the patients on the bone graft substitute side and in 29 patients on the autologous bone graft side of the spine (P > 0.05). One patient showed lucency and breakage of distal pedicle screw in autologous bone graft side. The interobserver agreement (kappa) had an average of 0.72 for graft incorporation, 0.75 for fusion on radiographs, and 0.88 for the CT scan findings.
Conclusion:
Hydroxyapatite and beta-tricalcium phosphate mixed with bone marrow aspirate seems to be a promising alternative to conventional autologous iliac bone graft for posterolateral spinal fusion.
doi:10.4103/0019-5413.49387
PMCID: PMC2762171  PMID: 19838344
Beta-tricalcium phosphate; bone marrow aspirate; hydroxyapatite; posterolateral spinal fusion
21.  Spontaneous Posterior Iliac Crest Regeneration Enabling Second Bone Graft Harvest; A Case Report 
HSS Journal  2009;5(2):114-116.
We present a case of a revision spinal fusion in which successful bone graft reharvesting was performed from the posterior iliac crest 4 years after initial intracortical harvesting. To date, only anterior iliac crest regeneration has been reported in orthopedic trauma patients. A 70-year-old man with a history of two prior instrumented lumbar fusion operations developed thoracolumbar kyphosis junctional to the lumbosacral fusion mass. His first operation was an instrumented posterolateral lumbar fusion L1 to L5, where bone graft was harvested from the right iliac crest using the intracortical harvesting technique. The second procedure was performed 18 months later and consisted of an extension of the fusion to the sacrum due to L5–S1 level derived symptoms. The bone graft for this procedure was taken with the same technique from the left iliac crest. The development of thoracolumbar junctional kyphosis necessitated the third operation, which consisted of a same-day anterior–posterior extension of the fusion to T10. Prior to this third procedure, a spinal computer tomography was performed that documented regeneration of the cancellous bone in the right iliac crest. This permitted reharvesting of almost 40 ml of cancellous bone using the intracortical bone harvesting technique from the right iliac crest. Histological analysis showed mature bone. Cancellous bone regeneration and restoration of the local anatomy of the ilium are possible after intracortical bone harvesting. This regeneration can provide autologous bone graft to assist fusion in subsequent operations.
doi:10.1007/s11420-009-9122-y
PMCID: PMC2744760  PMID: 19533248
posterior iliac crest bone graft; intracortical technique; bone harvesting; reharvesting; complications
22.  Effect of Hydroxyapatite porous characteristics on healing outcomes in rabbit posterolateral spinal fusion model 
European Spine Journal  2007;16(12):2215-2224.
Hydroxyapatite (HA) has been commonly used as a bone graft substitute in various kinds of clinical fields. To improve the healing capability of HA, many studies have been performed to reveal its optimal structural characteristics for better healing outcomes. In spinal reconstruction surgery, non-interconnected porous HAs have already been applied as a bone graft extender in order to avoid autogenous bone harvesting. However, there have been few experimental studies regarding the effects of the structural characteristics of HA in posterolateral lumbar intertransverse process spine fusion (PLF). The aims of this study were to investigate the effect of HA porous characteristics on healing outcomes in a rabbit PLF model in order to elucidate appropriate structural characteristics of HA as a bone graft extender. Thirty-six adult female Japanese White rabbits underwent bilateral intertransverse process fusion at the level of L5–6 without internal fixation. We prepared three types of HA with different porosities: HA with 15% porosity (HA15%), HA with 50% porosity (HA50%), and HA with 85% porosity (HA85%), all of which were clinically available materials. The HA15% and HA50% had few interconnecting pores, whereas the HA85%, which was a recently developed material, had abundant interconnecting pores. All rabbits were randomly divided into the following four groups according to the grafted materials: (1) HA15% + autogenous bone, (2) HA50% + autogenous bone, (3) HA85% + autogenous bone, (4) pure autogenous bone graft. The animals were euthanized at 5 weeks after surgery, and post-mortem analyses including biomechanical testing, radiographical and histological evaluations were performed. There was no statistically significant difference in either fusion rate and/or bending stiffness among the three HA groups. However, in histological and radiological analyses, both bone ingrowth rate and direct bone bonding rate in the HA85% group were significantly higher than those in the HA15% and HA50% groups, despite the similar value of bone volume rate in fusion mass among the three HA groups. In the HA85% group, bone ingrowth was achieved throughout the implanted HAs via interconnecting pores and there was excellent unification between the HA granules and the newly mineralized bone. On the other hand, in the non-interconnected porous HA groups, only a little bone ingrowth could be seen at the peripheral pores of the implanted HA, and its surface was mostly covered with fibrous tissue or empty space. The current study demonstrated that the HA porous characteristics had an effect on the histological outcomes in a rabbit PLF model. We would like to conclude that the interconnected high porous structure seems to be promising for the environment of PLF in the point of producing fusion mass with higher cellular viability. This is because the HA85% is superior in terms of integration with the newly formed bone in fusion mass compared to the non-interconnected porous HAs. However, the porous modifications of HA have little influence on fusion rate and mechanical strength because primary stabilization of the fusion segment is mainly achieved by bridging bone between the adjacent transverse processes outside the implanted materials, rather than the degree of integration between the newly formed bone and the HA granules in PLF.
doi:10.1007/s00586-007-0501-0
PMCID: PMC2140139  PMID: 17891422
Bone graft substitute; Hydroxyapatite; Spine fusion; Porous characteristics; Interconnecting pore
23.  Fate of the transpedicular intervertebral bone graft after posterior stabilisation of thoracolumbar fractures 
European Spine Journal  2002;11(3):251-257.
Abstract.
The authors present a retrospective clinical and radiological study addressing the outcome after posterior stabilisation of thoracolumbar fractures with intervertebral fusion via transpedicular bone grafting. The study included computed tomographic (CT) scan after implant removal for analysis of the intervertebral fusion and incorporation of the intervertebral bone graft and its influence on postoperative re-kyphosing. Twenty-nine patients with acute fractures of the thoracolumbar spine, treated between 1988 and 1995 at the Department of Trauma Surgery, Hannover Medical School, underwent posterior stabilisation and interbody fusion with transpedicular cancellous bone grafting. This study group was followed clinically and radiologically for a mean of 3.5 years. All patients underwent spiral CT scan with sagittal reconstruction after implant removal. Twenty-four type A, four type B, and one type C lesion were posteriorly stabilised and transpedicular intervertebral bone grafting was performed. The operative time averaged 2 h 50 min, the intraoperative fluoroscopy time 4 min 7 s, and the mean intraoperative blood loss was 376 ml. Four patients out of six with an incomplete neurologic lesion (Frankel/ASIA D) improved to Frankel/ASIA grade E. Two complications were observed: one delayed wound healing and one venous thrombosis with secondary pulmonary embolism. Compared to the preoperative status, our follow-up examinations demonstrated permanent social sequelae: the percentage of individuals able to do physical labor was reduced, whereas the proportion of unemployed or retired patients increased. The assessment of complaints and functional outcome with the Hannover Spine Score reflected a significant difference (P<0.001) between the status before injury (96.6/100 points) and at follow-up (64.4/100 points). The radiographic follow-up revealed a mean loss of correction of 7.8° (P<0.005). CT scans after implant removal showed an interbody fusion and incorporation of the transpedicular bone graft in ten patients (34%). In another ten patients (34%), the CT scans demonstrated the interbody fusion at the anterior and posterior walls of the vertebral body via direct contact due to collapse of the disc space. In these patients, the bone graft was not incorporated and no central interbody fusion could be found. In nine patients (31%) neither interbody fusion nor incorporation of the transpedicular graft was achieved. A frequent and reliable intervertebral fusion could not be achieved with the described technique of transpedicular bone grafting. The ineffectiveness of the intervertebral graft was found to be a reason for postoperative re-kyphosing.
doi:10.1007/s00586-001-0360-z
PMCID: PMC3610514  PMID: 12107794
Spinal injuries Spinal fusion Internal fixator Transpedicular bone grafting Treatment outcome
24.  Early Union of Grafted Bone in Ankylosing Spondylitis: Comparative Study with Degenerative Spinal Disease 
Clinics in Orthopedic Surgery  2010;2(4):209-213.
Background
Patients with ankylosing spondylitis (AS) achieve early bone union compared to those with other spinal diseases. This study compared the time to bone union after surgery between AS patients and degenerative spinal disease patients.
Methods
Patients with degenerative spinal diseases (control group) and AS (experimental group) underwent pedicle subtraction osteotomy followed by posterolateral fusion, and decompression and posterolateral fusion, respectively. There were 10 patients in the experimental group. The control group included 26 patients who were less than 50 years of age and underwent two-level autogenous grafting after decompression and spinal fusion. Autogenous grafts and a range of bone substitutes were used in the experimental group, whereas only autogenous grafts were used in the control group. Bone union was determined on the radiographs and 3-dimensional CT scan images. The level of union was assessed using the Lenke's and Christensen's classification systems.
Results
In the experimental group, the mean age was 41.3 years (range, 30 to 67 years), the mean follow-up period was 21.7 months (range, 12 to 43 months), and bone union was confirmed at an average of 3.5 months (range, 3 to 5 months) after surgery. In the control group, the mean age was 43.1 years (range, 35 to 50 years), the mean follow-up period was 21.8 months (range, 12 to 74 months), and bone union was observed at an average of 5.6 months (range, 4 to 12 months) after surgery. The difference in the time to bone union between the two groups was significant (p = 0.023).
Conclusions
The union of grafted bone was obtained earlier in patients with AS than in those with degenerative spinal diseases. Therefore, future studies should examine the factors affecting the early union in AS patients.
doi:10.4055/cios.2010.2.4.209
PMCID: PMC2981776  PMID: 21119936
Ankylosing spondylitis; Degenerative spinal disease; Bone graft
25.  Cotrel–Dubousset instrumentation in neuromuscular scoliosis 
European Spine Journal  2011;20(Suppl 1):75-84.
The study design is retrospective. The aim is to describe our experience about the treatment of patients with neuromuscular scoliosis (NMS) using Cotrel–Dubousset instrumentation. Neuromuscular scoliosis are difficult deformities to treat. A careful assessment and an understanding of the primary disease and its prognosis are essential for planning treatment which is aimed at maximizing function. These patients may have pelvic obliquity, dislocation of the hip, limited balance or ability to sit, back pain, and, in some cases, a serious decrease in pulmonary function. Spinal deformity is difficult to control with a brace, and it may progress even after skeletal maturity has been reached. Surgery is the main stay of treatment for selected patients. The goals of surgery are to correct the deformity producing a balanced spine with a level pelvis and a solid spinal fusion to prevent or delay secondary respiratory complications. The instrumented spinal fusion (ISF) with second-generation instrumentation (e.g., Luque–Galveston and unit rod constructs), are until 1990s considered the gold standard surgical technique for neuromuscular scoliosis (NMS). Still in 2008 Tsirikos et al. said that “the Unit rod instrumentation is a common standard technique and the primary instrumentation system for the treatment of pediatric patients with cerebral palsy and neuromuscular scoliosis because it is simple to use, it is considerably less expensive than most other systems, and can achieve good deformity correction with a low loss of correction, as well as a low prevalence of associated complications and a low reoperation rate.” In spite of the Cotrel–Dubousset (CD) surgical technique, used since the beginning of the mid 1980s, being already considered the highest level achieved in correction of scoliosis by a posterior approach, Teli et al., in 2006, said that reports are lacking on the results of third-generation instrumentation for the treatment of NMS. Patients with neuromuscular disease and spinal deformity treated between 1984 and 2008 consecutively by the senior author (G.D.G.) with Cotrel–Dubousset instrumentation and minimum 36 months follow-up were reviewed, evaluating correction of coronal deformity, sagittal balance and pelvic obliquity, and rate of complications. 24 patients (Friedreich’s ataxia, 1; cerebral palsy, 14; muscular dystrophy, 2; polio, 2; syringomyelia, 3; spinal atrophy, 2) were included. According the evidence that the study period is too long (1984–2008) and that in more than 20 years many things changed in surgical strategy and techniques, all patients were divided in two groups: only hooks (8 patients) or hybrid construct (16 patients). Mean age was 18.1 years at surgery (range 11 years 7 months–max 31 years; in 17 cases the age at surgery time was between 10 and 20 years old; in 6 cases it was between 20 and 30 and only in 1 case was over 30 years old). Mean follow-up was 142 months (range 36–279). The most frequent patterns of scoliosis were thoracic (10 cases) and thoracolumbar (9 cases). In 8 cases we had hypokyphosis, in 6 normal kyphosis and in 9 hyperkyphosis. In 8 cases we had a normal lordosis, in 11 a hypolordosis and in 4 a hyperlordosis. In 1 case we had global T4–L4 kyphosis. In 8 cases there were also a thoracolumbar kyphosis (mean value 24°, min 20°–max 35°). The mean fusion area included 13 vertebrae (range 6–19); in 17 cases the upper end vertebra was over T4 and in 11 cases the lower end vertebra was over L4 or L5. In 7 cases the lower end vertebra was S1 to correct the pelvic obliquity. In 5 cases the severity of the deformity (mean Cobb’s angle 84.2°) imposed a preoperative halo traction treatment. There were 5 anteroposterior and 19 posterior-only procedures. In 10 cases, with low bone quality, the arthrodesis was performed using iliac grafting technique while in the other (14 cases) using autologous bone graft obtained in situ from vertebral arches and spinous processes (in all 7 cases with fusion extended until S1, it was augmented with calcium phosphate). The mean correction of coronal deformity and pelvic obliquity averaged, respectively, 57.2% (min 31.8%; max 84.8%) and 58.9% (mean value preoperative, 18.43°; mean value postoperative, 7.57°; mean value at last follow-up, 7.57°). The sagittal balance was always restored, reducing hypo or hyperkyphosis and hypo or hyperlordosis. Also in presence of a global kyphosis, we observed a very good restoration (preoperatory, 65°; postoperatory, 18° kyphosis and 30° lordosis, unmodified at last f.u.). The thoracolumbar kyphosis, when present (33.3% of our group) was always corrected to physiological values (mean 2°, min 0°–max 5°). The mean intraoperative blood lost were 2,100 cc (min 1,400, max 5,350). Major complications affected 8.3% of patients, and included 1 postoperative death and 1 deep infection. Minor complications affected none of patients. CD technique provides lasting correction of spinal deformity in patients with neuromuscular scoliosis, with a lower complications rate compared to reports on second-generation instrumented spinal fusion.
doi:10.1007/s00586-011-1758-x
PMCID: PMC3087033  PMID: 21404030
Neuromuscular scoliosis; Cotrel–Dubousset; Spinal fusion

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