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1.  Balloon Kyphoplasty 
Executive Summary
Objective
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.
Conclusion
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
2.  The Role of the Orthopaedic Surgeon 
Treatment for patients with vertebral compression fractures (VCFs) should address pain and mobility, and aim to prevent further fractures. Restoration of vertebral height to improve the spinal deformity is also of primary importance. Traditionally, osteoporosis-induced VCFs have been treated with bed rest, narcotic analgesics, braces, and physical therapy. However, immobility is known to have a negative impact on muscle strength and bone mass and may cause serious general health complications, narcotics can worsen mood and mentation problems, and brace wear is not well tolerated by the elderly. These fractures have a considerable impact on quality of life, and although most of them heal, the height loss and deformity remain uncorrected. Vertebroplasty and balloon kyphoplasty are minimally invasive treatment options for VCFs. Kyphoplasty is designed to reduce and stabilise the fracture in a controlled way, to correct the spinal deformity and to provide immediate pain relief, mobility, and an improved quality of life. The main differences between balloon kyphoplasty and vertebroplasty are the greater potential of the kyphoplasty procedure to restore the vertebral height and kyphosis angle of the fractured vertebra and (although the clinical significance of this has not yet been demonstrated) its lower percentage of cement extravasation; the latter is related to lower injection pressures, and facilitated by a higher cement viscosity and by the cavity created in the fractured vertebrae.
Worldwide, over 95,000 VCFs in 75,000 patients have been treated with balloon kyphoplasty. Accordingly, the orthopaedic surgeon today plays a leading role in the “Fracture Unit”, not only on the therapeutic side, but also on the diagnostic side. The kyphoplasty kit can allow percutaneous bone biopsy, often very important in order to obtain a correct diagnosis. In order to justify resource allocation and patient selection for new osteoporotic fracture treatment technologies, it is also becoming increasingly important to determine the cost-effectiveness of treatments. In a recent study we highlighted why spine surgery is important in VCFs, comparing the efficacy and safety of kyphoplasty and of non-surgical management for the treatment of acute osteoporotic VCFs. Our aim was to test the hypothesis that kyphoplasty would result in greater improvement in quality of life with a better cost-effectiveness ratio at 24 months’ follow up. Between January 2005 and September 2008, we randomly assigned 60 patients with one fresh (< 6 weeks) painful osteoporotic VCF to undergo either percutaneous surgical treatment with Medtronic Kyphoplasty (Group A, n=32) or conservative treatment (Group B, n=28), preceded by 40 days of bed rest and followed by 40 days of hyperextension back brace wear (type C35). The baseline characteristics were similar in the two groups: the average age was 67 years and 7 months, min. 62 - max. 89 years, in Group A, and 66 years and 5 months, min. 64 - max. 78 years, in Group B. The fractured levels were T12=10, L1=11, L2=5, L3=6 in Group A and T12=7, L1=13, L2=5, L3=3 in Group B. According to the Magerl classification the VCFs in both groups were prevalently A1.2 (13 cases in A and 16 in B) and A1.3 (14 cases in A and 8 in B). In all cases standing lateral spinal radiographs were taken at baseline, 3 months, 6 months, 12 months and 24 months to evaluate vertebral kyphosis (VK) and regional kyphosis (RK). Vertebral kyphosis was measured from the superior endplate to the inferior endplate of the fractured vertebra. Regional kyphosis was measured from the inferior endplate of the intact adjacent distal vertebra to the superior endplate of the intact adjacent proximal vertebra. Pain was evaluated at baseline, 3 months, 6 months, 12 months and 24 months with the VAS pain scale. Each patient had a card to be used for recording medical and non-medical costs sustained in the course of the 24 months.
The primary endpoint was the difference, between the groups, in VK and VAS pain scale score changes from baseline to 3, 6, 12 and 24 months: the surgical treatment group always showed better results. Mean VK was 11.50 degrees at baseline, 6.50 degrees at 3 months, 6.37 degrees at 6 months, and 6.38 degrees at 12 and 24 months in Group A and 12.6 degrees at baseline, 10.50 degrees at 3 months, 10.70 degrees at 6 months, and 11.80 degrees at 12 and 24 months in Group B. The VAS pain score was 9 (baseline), 2 (3 mths), 1 (6 mths), 2 (12 and 24 mths) in Group A and 9 (baseline), 7 (3 mths), 4 (6 mths), 5 (12 and 24 mths) in Group B.
The secondary endpoint was the difference, between surgical and conservative treatments, in medical (hospitalisation, surgical procedure, convalescence and 24-months follow up) and non-medical costs sustained. Group A recorded higher hospitalisation costs (average 9 days, € 4551) than Group B (average 5 days, € 2681). For the surgically treated group there was also an additional surgical procedure cost (average € 4,483.09).
The convalescence was longer in Group B (average 95 days, medical costs: € 2018,59) than in Group A (average 15 days, medical costs: € 192,92). Obviously, non-medical costs were also higher in Group B (€ 3390,00) than in Group A (€ 210,00). Between 3 and 24 months we recorded three cases of back pain Group A and 17 in Group B, with an additional cost of € 47,53 in the first group and € 1319,56 in the second. Therefore, on the whole, the surgical treatment had an average cost of € 9484,54 while the conservative treatment had an average cost of € 9409,15. However it is important to underline that in the second group there was also another non-medical cost that is difficult to quantify: that of family caregiving, which corresponds to 1 person’s days of absence from work (average 14 days, min. 5, max. 22).
The cost-effectiveness relationship becomes even better for the surgically treated group if we analyse the complications. In the first group we recorded seven asymptomatic minor complications (3 cases of vein leakage and 4 of intradiscal leakage) that did not generate supplementary medical or non-medical costs; instead, in the second group we recorded 13 complications (6 cases of decubitus ulcers and 7 cases of bronchitis) generating an additional cost of ⇔ 4325. Therefore, this study confirmed that kyphoplasty may today be the gold standard in the treatment of fresh osteoporotic VCFs. Accordingly, orthopaedic surgeon is destined to play an ever more important role within a superspecialist team.
PMCID: PMC3213845
3.  Percutaneous Vertebroplasty for Treatment of Painful Osteoporotic Vertebral Compression Fractures 
Executive Summary
Objective of Analysis
The objective of this analysis is to examine the safety and effectiveness of percutaneous vertebroplasty for treatment of osteoporotic vertebral compression fractures (VCFs) compared with conservative treatment.
Clinical Need and Target Population
Osteoporosis and associated fractures are important health issues in ageing populations. Vertebral compression fracture secondary to osteoporosis is a cause of morbidity in older adults. VCFs can affect both genders, but are more common among elderly females and can occur as a result of a fall or a minor trauma. The fracture may occur spontaneously during a simple activity such as picking up an object or rising up from a chair. Pain originating from the fracture site frequently increases with weight bearing. It is most severe during the first few weeks and decreases with rest and inactivity.
Traditional treatment of painful VCFs includes bed rest, analgesic use, back bracing and muscle relaxants. The comorbidities associated with VCFs include deep venous thrombosis, acceleration of osteopenea, loss of height, respiratory problems and emotional problems due to chronic pain.
Percutaneous vertebroplasty is a minimally invasive surgical procedure that has gained popularity as a new treatment option in the care for these patients. The technique of vertebroplasty was initially developed in France to treat osteolytic metastasis, myeloma, and hemangioma. The indications were further expanded to painful osteoporotic VCFs and subsequently to treatment of asymptomatic VCFs.
The mechanism of pain relief, which occurs within minutes to hours after vertebroplasty, is still not known. Pain pathways in the surrounding tissue appear to be altered in response to mechanical, chemical, vascular, and thermal stimuli after the injection of the cement. It has been suggested that mechanisms other than mechanical stabilization of the fracture, such as thermal injury to the nerve endings, results in immediate pain relief.
Percutaneous Vertebroplasty
Percutaneous vertebroplasty is performed with the patient in prone position and under local or general anesthesia. The procedure involves fluoroscopic imaging to guide the injection of bone cement into the fractured vertebral body to support the fractured bone. After injection of the cement, the patient is placed in supine position for about 1 hour while the cement hardens.
Cement leakage is the most frequent complication of vertebroplasty. The leakages may remain asymptomatic or cause symptoms of nerve irritation through compression of nerve roots. There are several reports of pulmonary cement embolism (PCE) following vertebroplasty. In some cases, the PCE may remain asymptomatic. Symptomatic PCE can be recognized by their clinical signs and symptoms such as chest pain, dyspnea, tachypnea, cyanosis, coughing, hemoptysis, dizziness, and sweating.
Research Methods
Literature Search
A literature search was performed on Feb 9, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from January 1, 2005 to February 9, 2010.
Studies were initially reviewed by titles and abstracts. For those studies meeting the eligibility criteria, full-text articles were obtained and reviewed. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with an unknown eligibility were reviewed with a second clinical epidemiologist and then a group of epidemiologists until consensus was established. Data extraction was carried out by the author.
Inclusion Criteria
Study design: Randomized controlled trials (RCTs) comparing vertebroplasty with a control group or other interventions
Study population: Adult patients with osteoporotic vertebral fractures
Study sample size: Studies included 20 or more patients
English language full-reports
Published between Jan 1 2005 and Feb 9, 2010
(eligible studies identified through the Auto Alert function of the search were also included)
Exclusion Criteria
Non-randomized studies
Studies on conditions other than VCF (e.g. patients with multiple myeloma or metastatic tumors)
Studies focused on surgical techniques
Studies lacking outcome measures
Results of Evidence-Based Analysis
A systematic search yielded 168 citations. The titles and the abstracts of the citations were reviewed and full text of the identified citations was retrieved for further consideration. Upon review of the full publications and applying the inclusion and exclusion criteria, 5 RCTs were identified. Of these, two compared vertebroplasty with sham procedure, two compared vertebroplasty with conservative treatment, and one compared vertebroplasty with balloon kyphoplasty.
Randomized Controlled Trials
Recently, the results of two blinded randomized placebo-controlled trials of percutaneous vertebroplasty were reported. These trials, providing the highest quality of evidence available to date, do not support the use of vertebroplasty in patients with painful osteoporotic vertebral compression fractures. Based on the results of these trials, vertebroplasty offer no additional benefit over usual care and is not risk free.
In these trials the treatment allocation was blinded to the patients and outcome assessors. The control group received a sham procedure simulating vertebroplasty to minimize the effect of expectations and to reduce the potential for bias in self-reporting of outcomes. Both trials applied stringent exclusion criteria so that the results are generalizable to the patient populations that are candidates for vertebroplasty. In both trials vertebroplasty procedures were performed by highly skilled interventionists. Multiple valid outcome measures including pain, physical, mental, and social function were employed to test the between group differences in outcomes.
Prior to these two trials, there were two open randomized trials in which vertebroplasty was compared with conservative medical treatment. In the first randomized trial, patients were allowed to cross over to the other arm and had to be stopped after two weeks due to the high numbers of patients crossing over. The other study did not allow cross over and recently published the results of 12 months follow-up.
The following is the summary of the results of these 4 trials:
Two blinded RCTs on vertebroplasty provide the highest level of evidence available to date. Results of these two trials are supported by findings of an open randomized trial with 12 months follow-up. Blinded RCTs showed:
No significant differences in pain scores of patients who received vertebroplasty and patients who received a sham procedure as measured at 3 days, 2 weeks and 1 month in one study and at 1 week, 1 month, 3 months, and 6 months in the other.
The observed differences in pain scores between the two groups were neither statistically significant nor clinically important at any time points.
The above findings were consistent with the findings of an open RCT in which patients were followed for 12 months. This study showed that improvement in pain was similar between the two groups at 3 months and were sustained to 12 months.
In the blinded RCTs, physical, mental, and social functioning were measured at the above time points using 4-5 of the following 7 instruments: RDQ, EQ-5D, SF-36 PCS, SF-36 MCS, AQoL, QUALEFFO, SOF-ADL
There were no significant differences in any of these measures between patients who received vertebroplasty and patients who received a sham procedure at any of the above time points (with a few exceptions in favour of control intervention).
These findings were also consistent with the findings of an open RCT which demonstrated no significant between group differences in scores of ED-5Q, SF-36 PCS, SF 36 MCS, DPQ, Barthel, and MMSE which measure physical, mental, and social functioning (with a few exceptions in favour of control intervention).
One small (n=34) open RCT with a two week follow-up detected a significantly higher improvement in pain scores at 1 day after the intervention in vertebroplasty group compared with conservative treatment group. However, at 2 weeks follow-up, this difference was smaller and was not statistically significant.
Conservative treatment was associated with fewer clinically important complications
Risk of new VCFs following vertebroplasty was higher than those in conservative treatment but it requires further investigation.
PMCID: PMC3377535  PMID: 23074396
4.  Minimally invasive pedicle screw fixation combined with percutaneous vertebroplasty for preventing secondary fracture after vertebroplasty 
Background
Percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) could give rise to excellent outcomes and significant improvements in pain, analgesic requirements, function, cost, and incidence of serious complications for thoracolumbar osteoporotic vertebral compression fractures (VCFs). But some studies showed the recurrent fracture of a previously operated vertebra or adjacent vertebral fracture after PVP or PKP. The purpose of this study was to compare minimally invasive pedicle screw fixation (MIPS) and PVP with PVP to evaluate its feasibility and safety for treating acute thoracolumbar osteoporotic VCF and preventing the secondary VCF after PVP.
Methods
Sixty-eight patients with a mean age of 74.5 years (ranging 65 ~ 87 years), who sustained thoracic or lumbar fresh osteoporotic VCFs without neurologic deficits underwent the procedure of PVP (group 1, n = 37) or MIPS combined with PVP (group 2, n = 31). Visual analog scale pain scores (VAS) were recorded and Cobb angles, central and anterior vertebral body height were measured on the lateral radiographs before surgery and immediately, 1 month, 2 months, 3 months, 6 months, 1 year, and 2 years after surgery.
Results
The patients were followed for an average of 27 months (ranging 24–32 months). The VAS significantly decreased after surgery in both groups (P < 0.005). The central and anterior vertebral body height significantly increased (P < 0.005), and the Cobb angle significantly decreased (P < 0.05) immediately after surgery in both groups. No significant changes in both the Cobb angle correction and the vertebral body height gains obtained were observed at the end of the follow-up period in group 2. But the Cobb angle significantly increased (P < 0.005), and the central and anterior vertebral body height significantly decreased (P < 0.005) 2 years after surgery compared with those immediately after surgery in group 1, and there were five patients with new fracture of operated vertebrae and nine cases with fracture of adjacent vertebrae.
Conclusions
MIPS combined with PVP is a good choice for the treatment of acute thoracolumbar osteoporotic VCF, which can prevent secondary VCF after PVP.
doi:10.1186/s13018-015-0172-1
PMCID: PMC4352555  PMID: 25890296
Osteoporosis; Thoracolumbar vertebral fracture; Vertebroplasty; Percutaneous surgery; Pedicle screw fixation; Minimally invasive spinal surgery
5.  Risk factors predicting the new symptomatic vertebral compression fractures after percutaneous vertebroplasty or kyphoplasty 
European Spine Journal  2011;21(5):905-911.
Introduction
Percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) are effective procedures to alleviate pain caused by osteoporotic vertebral compression fractures (VCFs). New vertebral compression fracture (NVCF) has been noted as a potential late sequela of the procedures. The incidence of NVCFs and affecting risk factors were investigated.
Materials and methods
The authors retrospectively analyzed the occurrence of NVCFs in 147 patients treated with PVP or PKP for osteoporotic VCFs. Possible risk factors, such as age, gender, body mass index, bone mineral density (BMD), location of treated vertebra, treatment modality, amount of bone cement injected, anterior–posterior ratio of the fractured vertebra, cement leakage into the disc space, and pattern of cement distribution, were assessed.
Results
Twenty-seven patients (18.4%) had subsequent symptomatic NVCFs with a median time to new fracture was of 70 days. The 1-year symptomatic fracture-free rate was 85.0% by the Kaplan–Meier estimate. Eighteen (66.7%) of the 27 patients had an NVCF on the adjacent vertebra. Significant differences (P < 0.05) were found between the NVCF and control groups in regard to age, treatment modality, BMD, and the proportion of cement leakage into the disc space. Discal cement leakage and low BMD affected on adjacent NVCFs.
Conclusion
The most important risk factors affecting NVCFs were osteoporosis and intervertebral discal cement leakage.
doi:10.1007/s00586-011-2099-5
PMCID: PMC3337901  PMID: 22160212
Osteoporotic compression fracture; Vertebroplasty; Kyphoplasty; BMD; Discal leakage
6.  Comparative Clinical Results of Vertebroplasty Using Jamshidi® Needle and Bone Void Filler for Acute Vertebral Compression Fractures 
Korean Journal of Spine  2012;9(3):239-243.
Objective
Percutaneous vertebroplasty (PVP) is an effective treatment modality for management of osteoporotic compression fracture. However physicians sometimes have problems of high pressure in cement delivery and cement leakage when using Jamshidi® needle (JN). Bone void filler (BVF) has larger lumen which may possibly diminish these problems. This study aims to compare the radiologic and clinical outcome of JN and BVF for PVP.
Methods
One hundred twenty-eight patients were treated with PVP for osteoporotic vertebral compression fracture (VCF) where 46 patients underwent PVP with JN needle and 82 patients with BVF. Radiologic outcome such as kyphotic angle and vertebral body height (VBH) and clinical outcome such as visual analog scale (VAS) scores were measured after treatment in both groups.
Results
In JN PVP group, mean of 3.26 cc of polymethylmethacrylate (PMMA) were injected and 4.07 cc in BVF PVP group (p<0.001). For radiologic outcome, no significant difference in kyphotic angle reduction was observed between two groups. Cement leakage developed in 6 patients using JN PVP group and 2 patients using BVF group (p=0.025). No significant difference in improvement of VAS score was observed between JN and BVF PVP groups (p=0.43).
Conclusion
For the treatment of osteoporotic VCF, usage of BVF for PVP may increase injected volume of cement, easily control the depth and direction of PMMA which may reduce cement leakage. However, improvement of VAS score did not show difference between two groups. Usage of BVF for PVP may be an alternative to JN PVP in selected cases.
doi:10.14245/kjs.2012.9.3.239
PMCID: PMC4431009  PMID: 25983822
Vertebroplasty; Spinal fractures; Osteoporosis; Kyphoplasty
7.  Vertebroplasty for osteoporotic spine fracture: prevention and treatment 
European Spine Journal  2003;12(Suppl 2):S155-S162.
There is a relatively high prevalence of osteoporotic vertebral compression fractures (VCFs) in the elderly population, especially in women aged 50 or older. The result of these VCFs is increased morbidity and mortality in the short and long term. Medical treatment of these fractures includes bed rest, orthotics, analgesic medication and time. Percutaneous vertebroplasty (PVP) consists of percutaneous injection of biomaterial, such as methylmethacrylate, into the VCF to produce stability and pain relief. Biomechanical testing has shown that PVP can restore strength and stiffness of the vertebral body to the pre-fracture levels. Clinical results show immediate and maintained pain relief in 70–95% of the patients. Possible major complications include cement leakage into the spinal canal or into the venous system. Additionally, percutaneous vertebroplasty may alter the normal loading behavior of the adjacent vertebral body, and there is an increased risk of adjacent segment VCF. Kyphoplasty is a new technique, which introduces a balloon into the vertebral body transpedicularly to reduce the VCF while creating a cavity for the cement injection. This technique has the benefit of kyphosis reduction as well as less cement leakage. Research continues into the development of injectable biomaterials that are resorbable and allow for new bone formation. Vertebroplasty and kyphoplasty are safe and effective in the treatment of osteoporotic VCFs. They may allow for a faster return to function, and thus avoid the morbidity associated with medical treatment.
doi:10.1007/s00586-003-0607-y
PMCID: PMC3591824  PMID: 14505122
Vertebral compression fracture; Osteoporotic compression fracture; Percutaneous vertebroplasty; Vertebroplasty; Kyphoplasty
8.  Safety and Efficacy Studies of Vertebroplasty, Kyphoplasty, and Mesh-Container-Plasty for the Treatment of Vertebral Compression Fractures: Preliminary Report 
PLoS ONE  2016;11(3):e0151492.
To evaluate the clinical safety and efficacies of percutaneous vertebroplasty (PVP), percutaneous kyphoplasty (PKP), and percutaneous mesh-container-plasty (PMCP) for the treatment of vertebral compression fractures (VCFs), a retrospective study of 90 patients with VCFs who had been treated by PVP (n = 30), PKP (n = 30), and PMCP (n = 30) was conducted. The clinical efficacies of these three treatments were evaluated by comparing their PMMA cement leakages, cement patterns, height restoration percentages, wedge angles, visual analogue scales (VAS), and oswestry disability index (ODI) at the pre- and post-operative time points. 6.67%, 3.33%, and 0% of patients had PMMA leakage in PVP, PKP, and PMCP groups, respectively. Three (solid, trabecular, and mixed patterns), two (solid and mixed patterns), and one (mixed patterns) types of cement patterns were observed in PVP, PKP, and PMCP groups, respectively. PKP and PMCP treatments had better height restoration ability than PVP treatment. PVP, PKP, and PMCP treatments had significant and similar ability in pain relief and functional recovery ability for the treatment of VCFs. These results indicate minimally invasive techniques were effective methods for the treatment of VCFs. Moreover, these initial outcomes suggest PMCP treatment may be better than both PVP treatment and PKP treatment.
doi:10.1371/journal.pone.0151492
PMCID: PMC4786194  PMID: 26963808
9.  Extreme Multi-Level Percutaneous Vertebroplasty for Newly Developed Multiple Adjacent Compression Fractures 
Osteoporotic patients who undergo percutaneous vertebroplasty (PVP) have the risk of a repeated collapse of their adjacent vertebral body due to alteration of load transfer into the adjacent vertebral body. The authors have experienced a rare case of repeated osteoporotic vertebral compression fractures (VCF) resulting in extreme multi-level PVP. A 74-year-old female developed severe back pain after slipping down one month ago. Her X-ray and MR images indicated a T11 VCF. She underwent successful PVP with polymethylmethacrylate (PMMA). Two weeks later, she returned to our hospital due to a similar back pain. Repeated X-ray and MR images showed an adjacent VCF on T12. A retrial of PVP was performed on T12, which provided immediate pain relief. Since then, repeated collapses of the vertebral body occurred 12 times in 13 levels within a 24-month period. Each time the woman was admitted to our hospital, she was diagnosed of newly developed VCFs and underwent repeated PVPs with PMMA, which finally eased back pain. Based on our experience with this patient, repeated multiple PVP is not dangerous because its few and minor complications. Therefore, repeated PVP can serve as an effective treatment modality for extreme-multi level VCFs.
doi:10.3340/jkns.2009.45.6.378
PMCID: PMC2711237  PMID: 19609423
Percutaneous vertebroplasty; Extreme multi-level vertebropklasty compression fracture
10.  Prospective comparison of the therapeutic effect of teriparatide with that of combined vertebroplasty with antiresorptive agents for the treatment of new-onset adjacent vertebral compression fracture after percutaneous vertebroplasty 
Osteoporosis International  2011;23(5):1613-1622.
Summary
Most post-vertebroplasty new-onset adjacent vertebral compression fractures (VCFs) occur within 2–3 months, and antiresorptive agents do not significantly reduce the risk of their occurrence. In opposite mechanism, teriparatide directly stimulates bone formation and improves bone strength and quality faster. The therapeutic effect of teriparatide is better than that of vertebroplasty combined with an antiresorptive treatment and is a potentially useful therapy for new-onset adjacent VCFs after vertebroplasty.
Introduction
Following vertebroplasty, patients are at increased risk of new-onset adjacent-level VCFs. The therapeutic effect of antiresorptive agents is too slow, and they are associated with the risk of new VCFs. Teriparatide markedly increases bone formation and strength and reduces the incidence of new-onset VCFs. This prospective cohort study compared the therapeutic effects of teriparatide with those of combined vertebroplasty and an anti-resorber for treating new-onset adjacent VCFs after vertebroplasty.
Methods
Fifty patients with adjacent VCFs were randomly assigned to two groups: teriparatide only (group A) and additional vertebroplasty combined with an antiresorptive agent (group B). Relevant clinical data of the two groups were prospectively compared.
Results
The 22 patients in group A were at higher risk of new VCFs than those in group B (22 patients); they were older and had more pre-existing fractures (p < 0.05). Patients treated with teriparatide had a significantly lower incidence of new-onset VCFs (odds ratio = 0.21; 95% confidence interval, 0.02–2.10). Teriparatide-mediated VCF reduction was 78.57%, which was markedly better than that of group B. The teriparatide group had a significant decrease in the visual analog scale and an increase in the Japanese Orthopedic Association low back pain score after 6 months of treatment (p < 0.05). The increase in lumbar spine BMD was marked in the teriparatide group (21.70% vs. 6.87%) after an 18-month treatment.
Conclusions
Treatment of post-vertebroplasty adjacent VCFs with teriparatide (no new vertebroplasty) was more effective than that of repeated vertebroplasties combined with an anti-resorber.
doi:10.1007/s00198-011-1730-y
PMCID: PMC3332357  PMID: 21769661
Adjacent vertebral fracture; Antiresorptive agent; Teriparatide; Vertebral compression fracture; Vertebroplasty; Medicine & Public Health; Gynecology; Rheumatology; Orthopedics; Endocrinology
11.  The Incidence of New Vertebral Compression Fractures in Women after Kyphoplasty and Factors Involved 
Yonsei Medical Journal  2007;48(4):645-652.
Purpose
To identify the incidence of new vertebral compression fractures in women after kyphoplasty and to analyze influential factors in these patients.
Materials and Methods
One hundred and eleven consecutive female patients with osteoporotic vertebral compression fractures (VCFs) underwent kyphoplasty at 137 levels. These patients were followed for 15.2 months postoperatively. For the survey of new vertebral compression fractures, medical records and x-rays were reviewed, and telephone interviews were conducted with all patients.
Results
During that time 20 (18%) patients developed new VCFs. The rate of occurrence of new VCFs in one year was 15.5% using a Kaplan-Meier curve. Body mass index (BMI), symptom duration and kyphoplasty level were the statistically significant factors between the patient groups both with and without new VCFs after kyphoplasty. In the comparison between the adjacent and remote new VCF groups, the adjacent new VCF group showed a larger amount of polymethyl methacrylate (PMMA) use during kyphoplasty (p < 0.05). Before kyphoplasty, 9.9% of the patients had been prescribed medication for osteoporosis, and 93.7% of the patients started or continued medication after kyphoplasty. The development of new VCFs was affected by the number of vertebrae involved in the kyphoplasty. However, the lower incidence rate (15.5%) of new compression fractures might be due to a greater percentage (93.7% in our study) of patients taking anti-osteoporotic medication before and/or after kyphoplasty.
Conclusion
When kyphoplasty is planned for the management of patients with osteoporotic VCFs, the application of a small amount of PMMA can be considered in order to lower the risk of new fractures in adjacent vertebrae. The postoperative use of anti- osteoporotic medication is recommended for the prevention of new VCFs.
doi:10.3349/ymj.2007.48.4.645
PMCID: PMC2628047  PMID: 17722237
Kyphoplasty; compression fracture; influencing factor
12.  Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for osteoporotic vertebral compression fracture: A metaanalysis 
Indian Journal of Orthopaedics  2015;49(4):377-387.
Background:
Osteoporotic vertebral compression fracture (OVCF) is the most common complication of osteoporosis, however, debate persists over which procedure of percutaneous vertebroplasty (PVP) or balloon kyphoplasty (BKP) is a better treatment. We performed a metaanalysis of prospective, randomized controlled and clinical controlled trials of PVP and BKP to determine the efficacy and safety for the treatment of OVCFs to reach a relatively conclusive answer.
Materials and Methods:
We searched computerized databases comparing efficacy and safety of PVP and BKP in osteoporotic vertebral compression fractures. These reports included pain relief, functional capacity (Oswestry disability index [ODI] score), anterior vertebral body height (AVBH), kyphotic angle and complications (i.e. cement leakage, incident fractures). Studies were assessed for methodological bias and potential reasons for heterogeneity were explored.
Results:
As of March 15, 2013, a PubMed search resulted in 761 articles, of which eleven studies encompassing 789 patients, met the inclusion criteria. The average length of followup is 17 months and 4.6% patients were lost to followup. Results of metaanalysis indicated that BKP is more effective for short term pain relief. In addition, BKP is more effective to restore the AVBH (anterior vertebral body height), ODI and kyphotic angle of OVCFs. Moreover, BKP need more polymethylmethacrylate amount.
Conclusions:
In terms of better effectiveness of BKP procedure, we believe BKP to be superior over PVP for the treatment of osteoporotic VCFs.
doi:10.4103/0019-5413.154892
PMCID: PMC4510789  PMID: 26229156
Balloon kyphoplasty; metaanalysis; percutaneous vertebroplasty; vertebral compression fracture; Vertebroplasty; osteoporotic fractures; bone cements
13.  Risk Factors of New Compression Fractures in Adjacent Vertebrae after Percutaneous Vertebroplasty 
Asian Spine Journal  2011;5(3):180-187.
Study Design
Retrospective study.
Purpose
To evaluate risk factors related to the development of new fractures in adjacent vertebrae after percutaneous vertebroplasty.
Overview of Literature
Recent reports indicate that undue numbers of new fractures in adjacent vertebral bodies occur after percutaneous vertebroplasty.
Methods
One hundred four of 369 patients who underwent percutaneous vertebroplasty were followed for over 1 year. Fifty-four patients (51.9%) subsequently suffered from adjacent vertebral fractures. Age, lumbar lordotic angle, sacral slope, pelvic tilt, pelvic incidence, bone mineral density, amounts of cement injected, the restoration of vertebral height, kyphotic angle differences preexisting fracture, and intradiscal cement leakage were noted.
Results
Average bone mineral density was -3.52 in the fracture group and -2.91 in the fracture-free group; the risk of adjacent vertebral fracture increased as bone mineral density decreased (p < 0.05). Intradiscal cement leakage occurred in 18 patients (33.3%) in the fracture group, indicating that the risk of adjacent vertebral fracture increased with intradiscal cement leakage. In addition, 36 patients (66.7%) in the fracture group had a pre-existing fracture; thus, the presence of a preexisting fracture was found to be significantly associated with an increased risk of an adjacent vertebral fracture (p < 0.05). Higher restoration rates are associated with a greater likelihood of developing adjacent vertebral fractures (p < 0.05).
Conclusions
The factors found to contribute significantly to new fractures in adjacent vertebral bodies after percutaneous vertebroplasty were a lower bone mineral density, a greater restoration rate of vertebral height, a pre-existing fracture, and intradiscal cement leakage.
doi:10.4184/asj.2011.5.3.180
PMCID: PMC3159067  PMID: 21892391
Adjacent vertebral fractures; Percutaneous vertebroplasty; Risk factors
14.  Role of the supine lateral radiograph of the spine in vertebroplasty for osteoporotic vertebral compression fracture: a prospective study 
Background
Severely collapsed vertebral compression fracture (VCF) is usually considered as a contraindication for vertebroplasty because of critically decreased vertebral height (less than one-third the original height). However, osteoporotic VCF can possess dynamic mobility with intravertebral cleft (IVC), which can be demonstrated on supine lateral radiographs (SuLR) and standing lateral radiographs (StLR). The purposes of this study were to: (1) evaluate the efficacy of SuLR to detect IVCs and assess the intravertebral mobility in VCFs, and (2) evaluate the short-term results of vertebroplasty in severely collapsed VCFs with IVCs.
Methods
We enrolled 37 patients with 40 symptomatic osteoporotic VCFs for vertebroplasty; 11 had severely collapsed VCFs with concurrent IVCs detected on the SuLR, the others had not-severely collapsed VCFs. A preoperative StLR, SuLR, magnetic resonance imaging (MRI), and postoperative StLR were taken from all patients. Radiographs were digitized to calculate vertebral body morphometrics including vertebral height ratio and Cobb's kyphotic angle. The intensity of the patient's pain was assessed by the visual analogue scale (VAS) on the day before operation and 1 day, 1 month, and 4 months after operation. The patient's VAS scores and image measurement results were assessed with the paired t-test and Pearson correlation tests; Mann-Whitney U test was used for VAS subgroup comparison. Significance was defined as p < 0.05.
Results
IVCs in patients with not-severely collapsed VCFs were detected in 21 vertebrae (72.4%) by MRI, in 15 vertebrae (51.7%) by preoperative SuLR, and in 7 vertebrae (24.1%) by preoperative StLR. Using the MRI as a gold standard to detect IVCs, SuLR exhibit a sensitivity of 0.71 as compared to StLR that yield a sensitivity of 0.33. In patients with VCFs with IVCs detected on SuLR, the average of the postoperative restoration in vertebral height ratio was significantly higher than that in those without IVCs (17.1% vs. 6.4%). There was no statistical difference in the VAS score between severely collapsed VCFs with IVCs detected on SuLR and not-severely collapsed VCFs at any follow-up time point.
Conclusions
The SuLR efficiently detects an IVC in VCF, which indicates a better vertebral height correction after vertebroplasty compared to VCF without IVC. Before performing a costly MRI, SuLR can identify more IVCs than StLR in patients with severely collapsed VCFs, whom may become the candidates for vertebroplasty.
doi:10.1186/1471-2474-11-164
PMCID: PMC2918541  PMID: 20642815
15.  Preliminary Results for the Treatment of a Pain-Causing Osteoporotic Vertebral Compression Fracture with a Sky Bone Expander 
Korean Journal of Radiology  2008;9(5):420-425.
Objective
Vertebral compression fractures (VCFs) are common complications of osteoporosis. The expansion of VCFs with a Sky Bone Expander is a new procedure which improves kyphotic deformities and decreases pain associated with VCFs. The purpose of this study was to investigate the preliminary results for the treatment of painful osteoporotic VCFs with a Sky Bone Expander.
Materials and Methods
Twenty-six patients with pain-causing VCFs were treated with a Sky Bone Expander. This operation involved the percutaneous insertion of the Sky Bone Expander into a fractured vertebral body transpedicularly. Following the expansion, the Sky Bone Expander was contracted and removed, resulting in a cavity to be filled with bone cement. All fractures were analyzed for improvement in sagittal alignment. Clinical complications, pain relief and ambulation status were evaluated 1 day, 1 week, 1 month, and 3 months after the operation.
Results
Twenty-four hours after the operation, all the patients treated experienced some degree of pain relief. In addition, no postoperative neurologic complications were noted. The average operative time was 42.4 ± 15.5 min per vertebra. Moreover, an average cement volume of 3.5 mL (range, 2.5 ± 5.0 mL) was injected per vertebra. The average anterior height was 18.4 ± 5.1 mm preoperatively and 20.5 ± 5.3 mm postoperatively (p < 0.01). Furthermore, the average midline height was 15.5 ± 5.2 mm preoperatively and 18.9 ± 4.0 mm postoperatively (p < 0.01). The Cobb angle improved from 18.5 ± 8.2 degrees preoperatively to 9.2 ± 4.0 degrees postoperatively (p < 0.01). The Visual Anabog Scale scores decreased from 7.7 ± 1.8 points preoperatively to 3.1 ± 2.0, 2.9 ± 1.7, 2.6 ± 1.5 and 2.9 ± 11.3 after 1 day, 1 week, 1 month and 3 months after the operation, respectively. Cement extrusion was observed in four patients without any neurologic symptoms.
Conclusion
As a result of this study, we can postulate that the expansion of compressed vetrebra with a Sky Bone Expander is a safe and minimally invasive procedure resulting in the restoration of vertebral body height and the relief of pain associated with VCFs.
doi:10.3348/kjr.2008.9.5.420
PMCID: PMC2627204  PMID: 18838851
Osteoporosis; Vertebral compression fracture; Kyphoplasty
16.  A prospective study of percutaneous vertebroplasty for chronic painful osteoporotic vertebral compression fracture 
Vertebral compression fractures can be treated with percutaneous vertebroplasty, which involves the injection of bone cement into the affected vertebra, and leads to both relief of pain and stabilization of the fracture. However, this technique has not been extensively studied in the context of chronic compression fractures of the vertebrae, which may be more refractory to treatment. Accordingly, this study assessed the success of percutaneous vertebroplasty in 62 patients with painful vertebral compression fractures that had persisted for at least three months.
BACKGROUND:
Percutaneous vertebroplasty (PVP) for patients with chronic painful osteoporotic compression fractures has not been extensively studied.
OBJECTIVE:
To prospectively evaluate the efficacy of PVP for patients with chronic painful osteoporotic vertebral compression fractures (VCFs).
METHODS:
Sixty-two consecutive patients with chronic painful osteoporotic VCFs for ≥3 months underwent PVP. All procedures were performed under local anesthesia. The outcomes were pain relief at one week, one month, three months, six months and one year, as measured by visual analogue scale, Oswestry Disability Index, Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and Roland Morris Disability Questionnaire scores.
RESULTS:
The PVP procedures were technically successful and well tolerated in all patients. Sixty-two patients underwent PVP on 92 vertebrae in 73 procedures three to five days after referral, and no 30-day mortality was observed. Compared with baseline scores, improvement in visual analogue scale, Oswestry Disability Index, QUALEFFO and Roland Morris Disability Questionnaire scores was significantly greater after PVP at one week (P<0.001), one month (P<0.001), three months (P<0.001), six months (P<0.001) and one year (P<0.001), and the number of patients using drugs for pain treatment was significantly reduced. Five new fractures were reported in five of 62 patients treated with PVP during follow-up.
CONCLUSION:
PVP is effective in patients with chronic painful osteoporotic VCFs. Pain relief after PVP was immediate, was sustained for one year and may be an important factor for reducing persistent pain.
PMCID: PMC4325899  PMID: 24945287
Osteoporosis; Pain; Percutaneous vertebroplasty; Vertebral compression fracture
17.  Transpedicle body augmenter for vertebral augmentation in symptomatic multiple osteoporotic compression fractures 
Indian Journal of Orthopaedics  2010;44(2):191-197.
Background:
Multiple osteoporotic vertebral compression fractures (VCFs) have been treated with polymethylmethacrylate augmentation; however, there are cement complications and long-term fracture healing that are unknown. Transpedicle body augmenter (a porous titanium spacer) has been reported as an internal support to reconstruct the vertebral body combining short-segment fixation in burst fracture and Kümmell's disease with cord compression. Transpedicle body augmenter for vertebral augmentation (TpBA) also has been reported successfully in treating single painful VCF and vertebral metastasis lesions including pending fractures and pathologic compression fractures. To test the hypothesis that TpBA can effectively and safely treat the symptomatic multiple VCFs, this retrospective study was done by analyzing the radiographic and clinical results.
Materials and Methods:
We retrospectively reviewed clinical and radiographic results of TpBA for symptomatic multiple (more than two levels) VCFs in 62 patients with a total of 236 levels, i.e. 3.8 VCFs per patient. Manual reduction and TpBA via paramedian incisions with blunt dissection were done. One incision was made for two continuous levels and alternative side was selected for next incision. Mean age was 74.3 years (range, 62-87 years), and female-male ratio was 5.2:1. Anterior vertebral height and wedge angle by radiographic findings were measured at preoperative, initial follow-up and final follow-up. Clinical results were assessed by questionnaires and clinical observations. By July 2008, 58 patients returned to answer the questionnaire including quantification of pain on the visual analog scale, the response to operations (better, same, or worse after operation), returned to their pre-fracture function (yes/no) and satisfaction (a scale of 0 = completely dissatisfied to 10 = completely satisfied).
Results:
The mean symptom duration was 7 months, and follow-up, 48 months. The average operation time was 21 min per level, blood loss was 74 cc per level and hospitalization was 4.4 days. No patient had neurological deterioration. There was no dislodgement of implant in the final visit. Forty-eight patients (77.4%) could walk within 6-8 h after operation and the others, within 24 h. The anterior vertebral restoration was 7.3 mm initially and 6.2 mm at final follow-up. Wedge angle correction was 10.4° initially and was 9.3° at final follow-up. Pain, by the visual analog scale, was 8.5 preoperatively, 2.7 at day 7 follow-up and 2.9 at final follow-up. By the questionnaire, 52 of 58 respondents reported a decrease in discomfort after TpBA and 48 of 58 patients reported a return to normal activity after operation. The final satisfaction rate was 89.7%.
Discussion:
The symptoms of multiple osteoporotic compression fracture may be due to unstable fracture, radiculopathy, and global traumatic kyphosis with posture changes, which can be corrected by multiple TpBA. The transpedicle body augmenter was initially stabilized by the sinking and locking mechanism and finally by bone ingrowth.
Conclusions:
TpBA via a minimally invasive method led to early and medium-term clinical improvements and anatomic restoration of multiple symptomatic VCFs.
doi:10.4103/0019-5413.62016
PMCID: PMC2856395  PMID: 20419007
Vertebral compression fracture; osteoporosis; transpedicle body augmenter
18.  The Prognostic Factors Influencing on the Therapeutic Effect of Percutaneous Vertebroplasty in Treating Osteoporotic Vertebral Compression Fractures 
Objective
This retrospective study of 215 patients with 383 symptomatic osteoporotic vertebral compression fractures (VCFs) treated by percutaneous vertebroplasty (PVP), was performed to evaluate the clinical outcomes, and to analyze the various clinical factors affecting these results.
Methods
The authors assessed the clinical outcome under the criteria such as the pain improvement, activity, requirement of analgesics, and the patient's satisfaction, and determined the relation to various peri- and intra-operative factors, and postoperative imaging findings.
Results
The outcome was determined as 84.2% in relief of pain, 72.0% in change in activity, 65.7% in analgesics use, and 84.7% of satisfaction rate. More severe focal back pain, high uptake bone scan, and the lower mean T-score were related to the better pain relief following PVP. The longer the duration between fracture and PVP, the less severe focal back pain, low uptake bone scan, and leakage of PMMA into the paravertebral space were related to the less improvement in activity. Female and low uptake bone scan showed a correlation with more analgesic use. The longer the duration between fracture and PVP, low uptake bone scan, and the higher the mean T-score were correlated with the less the patients satisfaction.
Conclusion
Our study suggests that PVP may be more effective in the acute phase of VCFs, more severe focal pain, and far advanced osteoporosis on BMD. Leakage of PMMA into the paravertebral spcae also could be affecting the surgical results.
doi:10.3340/jkns.2009.45.1.16
PMCID: PMC2640817  PMID: 19242566
Osteoporosis; Vertebral compression fracture; Vertebroplasty
19.  Recompression of vertebral body after balloon kyphoplasty for osteoporotic vertebral compression fracture 
European Spine Journal  2010;19(11):1907-1912.
The purpose of this retrospective clinical study was to evaluate the factors that affect recompression of operated vertebrae after percutaneous balloon kyphoplasty (PKP) for osteoporotic vertebral compression fractures (VCFs) and assess their clinical importance. PKP has been used for VCFs with satisfactory results. Several studies about subsequent VCFs adjacent to cemented vertebrae have been reported after PKP. However, the presence and significance of recompression of operated vertebrae have not been adequately described. In total, 80 patients treated with PKP for single thoracolumbar VCFs were reviewed. The follow-up period was at least 1 year. Patients were divided into those without recompression (maintained group, n = 70) and those with recompression (recompressed group, n = 10). Plain roentgenography (preoperative, operative, and last), preoperative BMD, and preoperative MRI were checked. Age, gender, T-score in BMD, duration of symptom, compression rate (CR) of VCF, reduction rate, kyphotic angle (KA), reduction angle, intervertebral cleft (IVC), and non-PMMA-endplate-contact (NPEC) were evaluated. To evaluate the clinical results, we checked the VAS score at each follow-up period. All data were analyzed statistically. The CR for the recompressed group increased significantly after surgery and decreased at the last follow-up (p < 0.05). The last CR was not significantly different from the preoperative CR. The KA showed the same pattern. The preoperative, postoperative, and last VAS scores were significantly different from one another in both groups (p < 0.05). Between the groups, preoperative KA, postoperative KA, last KA, IVC, and NPEC were significantly different (p < 0.05). In particular, last KA, IVC, and NPEC showed highly significant differences (p < 0.001). In a correlation test for the evaluated factors, IVC (r = 0.557) and NPEC (r = 0.496) were the most significant. The presence of IVC and NPEC may play an important role in inducing recompression of treated vertebrae after PKP. Careful observation of patients with these conditions is necessary to prevent deterioration of their clinical course.
doi:10.1007/s00586-010-1479-6
PMCID: PMC2989275  PMID: 20559850
Osteoporotic vertebral compression fracture; Percutaneous kyphoplasty; Recompression; Intervertebral cleft; Non-PMMA-endplate-contact
20.  Is There Really No Benefit of Vertebroplasty for Osteoporotic Vertebral Fractures? A Meta-analysis 
Background
Osteoporotic vertebral compressed fractures (VCFs) are the most common osteoporotic fractures. Although percutaneous vertebroplasty (PVP) reportedly relieves pain and improves function, a recent pooled analysis from two multicenter randomized controlled trials concluded the improvement in pain and disability treated with PVP was similar to those with sham surgery.
Questions/Purpose
Using meta-analysis we therefore asked whether compared with either nonoperative therapy or a sham injection for patients with VCF, PVP would (1) better relieve pain, (2) provide greater improvement in pain-related disability, and (3) increase the recurrence of vertebral fractures.
Methods
We searched PubMed, EMBASE, Medline, and the Cochrane library using the keywords “vertebroplasty AND osteoporosis OR fracture”. We included nine of the 469 articles identified. Using a random effects model, we calculated the weighted mean differences to evaluate the pain reduction at different times as the primary outcome. Pain-related disability was assessed by a quality of life (QOL) measure. Improvement of QOL and recurrence of vertebral fractures were the secondary outcomes. We used subgroup analysis to reinvestigate pain relief and function improvement of PVP based on two different controls: nonoperative therapy and sham injection. The total number of patients was 886.
Results
Pain scoring was similar between the PVP group and the sham injection group at 1 to 29 days and 90 days. However, compared with nonoperative therapy, PVP reduced pain at all times studied. QOL in the PVP group was improved or tended to be improved compared with QOL for both control groups. The risk of new fractures was similar between the PVP groups and both control groups.
Conclusions
Different control groups may have accounted for the different conclusions in the literature regarding the ability of PVP to relieve pain and restore function recovery. Compared with nonoperative treatment PVP relieved pain better and improved QOL. PVP did not increase the risk of new fractures.
Level of Evidence
Level II, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-012-2404-6
PMCID: PMC3442000  PMID: 22729693
21.  Vertebral compression fractures after spine irradiation using conventional fractionation in patients with metastatic colorectal cancer 
Radiation Oncology Journal  2014;32(4):221-230.
Purpose
To evaluate the risk of vertebral compression fracture (VCF) after conventional radiotherapy (RT) for colorectal cancer (CRC) with spine metastasis and to identify risk factors for VCF in metastatic and non-metastatic irradiated spines.
Materials and Methods
We retrospectively reviewed 68 spinal segments in 16 patients who received conventional RT between 2009 and 2012. Fracture was defined as a newly developed VCF or progression of an existing fracture. The target volume included all metastatic spinal segments and one additional non-metastatic vertebra adjacent to the tumor-involved spines.
Results
The median follow-up was 7.8 months. Among all 68 spinal segments, there were six fracture events (8.8%) including three new VCFs and three fracture progressions. Observed VCF rates in vertebral segments with prior irradiation or pre-existing compression fracture were 30.0% and 75.0% respectively, compared with 5.2% and 4.7% for segments without prior irradiation or pre-existing compression fracture, respectively (both p < 0.05). The 1-year fracture-free probability was 87.8% (95% CI, 78.2-97.4). On multivariate analysis, prior irradiation (HR, 7.30; 95% CI, 1.31-40.86) and pre-existing compression fracture (HR, 18.45; 95% CI, 3.42-99.52) were independent risk factors for VCF.
Conclusion
The incidence of VCF following conventional RT to the spine is not particularly high, regardless of metastatic tumor involvement. Spines that received irradiation and/or have pre-existing compression fracture before RT have an increased risk of VCF and require close observation.
doi:10.3857/roj.2014.32.4.221
PMCID: PMC4282996  PMID: 25568850
Spinal neoplasm; Compression fractures; Spinal fractures; Radiotherapy; Colorectal cancer; Risk factors
22.  Risk Factors of New Adjacent Compression Fracture after Percutaneous Vertebroplasty: Effectiveness of Bisphosphonate in Osteoporotic or Osteopenic Elderly Patients 
Korean Journal of Neurotrauma  2014;10(2):86-91.
Objective
The purpose of this study is to investigate the incidence of new compression and to analyze factors that influence the fractures in adjacent levels after percutaneous vertebroplasty (PVP).
Methods
This retrospective study examined 206 patients who had undergone PVP for single level osteoporotic or osteopenic compression fractures during the last seven years in our department. After PVP, the patients were observed for at least over one year, and 29 patients showed new additional compression fractures in adjacent levels. One hundred seventy seven patients who did not show additional compression fractures were analyzed as the control group. Statistical comparisons were performed between the groups, in terms of age, gender, bone mineral density, whether bisphosphonate (BPP) was treated, preoperative kyphosis, preoperative wedge angle, change in wedge angle, amount of bone cement, existence of intradiscal bone cement leakage, and initial fracture levels.
Results
The statistically significant factors that influence new compression fractures in adjacent levels after PVP were as follows: being female, initial thoracolumbar junction fracture, preoperative large kyphotic, preoperative large wedge angle, change in wedge angle, administration of BPP in osteopenia group, and intradiscal cement leakage.
Conclusion
This study identified many factors that influence newly developed compression fractures in adjacent levels after PVP. Interestingly, the administration of BPP in osteopenia group had positive influence on new fractures in this study. Therefore, we recommend early administration of BPP to patients with osteopenia.
doi:10.13004/kjnt.2014.10.2.86
PMCID: PMC4852619  PMID: 27169040
Spinal fractures; Fractures compression; Adjacent vertebral fractures; Diphosphonates; Risk factors; Vertebroplasty
23.  The efficacy of a percutaneous expandable titanium device in anatomical reduction of vertebral compression fractures of the thoracolumbar spine 
Saudi Medical Journal  2015;36(1):52-60.
Objectives:
To evaluate the feasibility of a minimally invasive technique using a titanium expandable device to achieve anatomical restoration of vertebral compression fractures (VCF) of the thoracolumbar spine.
Methods:
This prospective study included 27 patients diagnosed with VCF (Magerl classification A.1.2, A.1.3, and A.3.1) of the thoracolumbar spine treated with percutaneous cement augmentation using the SpineJack® device. The study was conducted in Valladolid University Hospital, Valladolid, Spain from January to December 2012, with a minimum one-year follow up. Preoperative evaluation included visual analogue scale (VAS) for pain, and radiological assessment of the VCF using 3-dimensional computed tomography (3D-CT) scans for measurements of vertebral heights and angles. The patients were followed at 3, 6, and 12 months with clinical VAS and radiological assessments.
Results:
The procedure was performed in 27 patients with a mean age of 55.9 ± 17.3 years, 55.6% females. All patients underwent surgery within 6 weeks from time of injury. No procedure related complications occurred. Pain measured by VAS score decreased from 7.0 preoperatively to 3.2 within 24 hours, and remained 2.2 at 3 months, 2.1 at 6 months, and 1.5 at 12-months follow-up (p<0.05). Mean height restorations for the anterior was 3.56 mm, central was 2.49, and posterior vertebral was 1.28 mm, and maintained at 12-months follow-up (p=0.001).
Conclusion:
This new percutaneous technique for VCF has shown good clinical results in pain control and the possibility to reduce both vertebral kyphosis angles and fractured endplates seen in 3D-CT scans assessment method. Further studies are needed to confirm those results on larger cohorts with long-term follow up.
doi:10.15537/smj.2015.1.9463
PMCID: PMC4362189  PMID: 25630005
24.  Transpedicle body augmenter in painful osteoporotic compression fractures 
European Spine Journal  2006;16(5):589-598.
Osteoporotic compression fractures (VCFs) can result in progressive kyphosis and chronic pain. Polymethylmethacrylate has been used for augmentation of VCFs; however, there are cement complications, and long-term fracture healing is unknown. The transpedicle body augmenter (TpBA), a porous titanium spacer, has been reported as an internal support to reconstruct the vertebral body combining short segment fixation in burst fracture. We retrospectively reviewed radiographic and clinical results of TpBA vertebroplasty for single symptomatic VCF in 80 patients. Manual reduction and TpBA vertebroplasty via a paramedian incision with blunt dissection was done. Mean age was 72.3 years (range 51–87 years), and female–male ratio was 66:14. The mean symptom duration was 5 months, and follow-up 44 months. Peri-operative variables and radiographic and clinical results were evaluated. The average operation time was 26.1 min, blood loss 92 cc, and hospitalization 2.3 days. No patient had neurological deterioration. TpBA was found sinking into vertebral body initially, then locked by residual cortex, and finally stabilized within the vertebra. There was no dislodgement of TpBA in the final visit. Sixty-two patients (77.5%) could walk within 3–6 h after operation and the others within 24 h. The anterior vertebral restoration was 8.0 mm initially and 6.1 mm at final follow-up. Wedge angle correction was 11.5° initially and 9.4° at final follow-up. Pain, by the visual analog scale, was 8.6 pre-operatively, 2.5 at day 7 follow-up, and 2.9 at final follow-up. By the questionnaire, 72 of 76 respondents reported a decrease in discomfort after TpBA vertebroplasty, and 63 of 76 patients reported a return to normal activity after operation. The final satisfaction rate was 93.4%. TpBA vertebroplasty led to early and medium-term clinical improvement and anatomic restoration of painful VCFs.
doi:10.1007/s00586-006-0197-6
PMCID: PMC2213539  PMID: 16957946
Osteoporosis; Vertebral compression fracture; Vertebroplasty; TpBA; Manual reduction
25.  Percutaneous Stabilization System Osseofix® for Treatment of Osteoporotic Vertebral Compression Fractures - Clinical and Radiological Results after 12 Months 
PLoS ONE  2013;8(6):e65119.
Study Design
A prospective consecutive cohort study (follow-up study).
Objective
Our study investigated whether implantation of an expandable titanium mesh cage (Osseofix®) is a successful and safe minimally invasive therapy for osteoporotic vertebral compression fractures (VCF). Our experiences, clinical and radiological findings after 12 months follow-up are presented. Kypho- and vertebroplasty are well-established minimally invasive procedures for the treatment of osteoporotic VCF. The main complications associated with both procedures are uncontrolled bone cement leakage. Therefore a suitable alternative has been investigated.
Methods
During June 2010 to May 2011 24 patients were included with 32 osteoporotic VCF (T6 to L4). All of them were stabilized with the Osseofix® system. Preinterventionally we performed X-ray, MRI, and bone density measurements (DXA). Clinical and radiological results were evaluated preop., postop. and after 12 months postop. based on the Oswestry Disability Index (ODI) and the Visual Analogue Scale (VAS), X-ray (Beck Index, Cobb-angle) and CT.
Results
There was a significant improvement in the mean ODI (70,6% to 30,1%) as well as a significant reduction in pain intensity (VAS) (7,7 to 1,4) after 12 month. The mean kyphotic angle according to Cobb showed significant improvements (11,7° to 10,4°) after 12 months. Postinterventional imaging showed only one case of loss of height in a stabilized vertebral body (3.1%). We saw no changes in posterior vertebral wall or adjacent fractures. Except for one pronounced postoperative hematoma we saw no surgical complications including no cement leakage.
Conclusions
Stabilization of symptomatic osteoporotic VCF with Osseofix® system is a safe and effective procedure, even in fractures with posterior wall involvement. The clinical mid-term results are good at a very low complication rate. The Osseofix® system is an interesting alternative to the established procedures of cement augmentation.
doi:10.1371/journal.pone.0065119
PMCID: PMC3694101  PMID: 23840316

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