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1.  Balloon Kyphoplasty 
Executive Summary
To review the evidence on the effectiveness and cost-effectiveness of balloon kyphoplasty for the treatment of vertebral compression fractures (VCFs).
Clinical Need
Vertebral compression fractures are one of the most common types of osteoporotic fractures. They can lead to chronic pain and spinal deformity. They are caused when the vertebral body (the thick block of bone at the front of each vertebra) is too weak to support the loads of activities of daily living. Spinal deformity due to a collapsed vertebral body can substantially affect the quality of life of elderly people, who are especially at risk for osteoporotic fractures due to decreasing bone mass with age. A population-based study across 12 European centres recently found that VCFs have a negative impact on health-related quality of life. Complications associated with VCFs are pulmonary dysfunction, eating disorders, loss of independence, and mental status change due to pain and the use of medications. Osteoporotic VCFs also are associated with a higher rate of death.
VCFs affect an estimated 25% of women over age 50 years and 40% of women over age 80 years. Only about 30% of these fractures are diagnosed in clinical practice. A Canadian multicentre osteoporosis study reported on the prevalence of vertebral deformity in Canada in people over 50 years of age. To define the limit of normality, they plotted a normal distribution, including mean and standard deviations (SDs) derived from a reference population without any deformity. They reported a prevalence rate of 23.5% in women and a rate of 21.5% in men, using 3 SDs from the mean as the limit of normality. When they used 4 SDs, the prevalence was 9.3% and 7.3%, respectively. They also found the prevalence of vertebral deformity increased with age. For people older than 80 years of age, the prevalence for women and men was 45% and 36%, respectively, using 3 SDs as the limit of normality.
About 85% of VCFs are due to primary osteoporosis. Secondary osteoporosis and neoplasms account for the remaining 15%. A VCF is operationally defined as a reduction in vertebral body height of at least 20% from the initial measurement. It is considered mild if the reduction in height is between 20% and 25%; moderate, if it is between 25% and 40%; and severs, if it is more than 40%. The most frequently fractured locations are the third-lower part of the thorax and the superior lumbar levels. The cervical vertebrae and the upper third of the thorax are rarely involved.
Traditionally, bed rest, medication, and bracing are used to treat painful VCFs. However, anti-inflammatory and narcotic medications are often poorly tolerated by the elderly and may harm the gastrointestinal tract. Bed rest and inactivity may accelerate bone loss, and bracing may restrict diaphragmatic movement. Furthermore, medical treatment does not treat the fracture in a way that ameliorates the pain and spinal deformity.
Over the past decade, the injection of bone cement through the skin into a fractured vertebral body has been used to treat VCFs. The goal of cement injection is to reduce pain by stabilizing the fracture. The secondary indication of these procedures is management of painful vertebral fractures caused by benign or malignant neoplasms (e.g., hemangioma, multiple myeloma, and metastatic cancer).
The Technology
Balloon kyphoplasty is a modified vertebroplasty technique. It is a minimally invasive procedure that aims to relieve pain, restore vertebral height, and correct kyphosis. During this procedure, an inflatable bone tamp is inserted into the collapsed vertebral body. Once inflated, the balloon elevates the end plates and thereby restores the height of the vertebral body. The balloon is deflated and removed, and the space is filled with bone cement. Creating a space in the vertebral body enables the application of more viscous cement and at a much lower pressure than is needed for vertebroplasty. This may result in less cement leakage and fewer complications. Balloons typically are inserted bilaterally, into each fractured vertebral body. Kyphoplasty usually is done under general anesthesia in about 1.5 hours. Patients typically are observed for only a few hours after the surgery, but some may require an overnight hospital stay.
Health Canada has licensed KyphX Xpander Inflatable Bone Tamp (Kyphon Inc., Sunnyvale, CA), for kyphoplasty in patients with VCFs. KyphX is the only commercially available device for percutaneous kyphoplasty. The KyphX kit uses a series of bone filler device tubes. Each bone filler device must be loaded manually with cement. The cement is injected into the cavity by pressing an inner stylet.
In the United States, the Food and Drug Administration cleared the KyphX Inflatable Bone Tamp for marketing in July 1998. CE (Conformité European) marketing was obtained in February 2000 for the reduction of fracture and/or creation of a void in cancellous bone.
Review Strategy
The aim of this literature review was to evaluate the safety and effectiveness of balloon kyphoplasty in the treatment of painful VCFs.
INAHTA, Cochrane CCTR (formerly Cochrane Controlled Trials Register), and DSR were searched for health technology assessment reports. In addition, MEDLINE, EMBASE, and MEDLINE In-Process & Other Non-Indexed Citations were searched from January 1, 2000 to September 21, 2004. The search was limited to English-language articles and human studies.
The positive end points selected for this assessment were as follows:
Reduction in pain scores
Reduction in vertebral height loss
Reduction in kyphotic (Cobb) angle
Improvement in quality of life scores
The search did not yield any health technology assessments on balloon kyphoplasty. The search yielded 152 citations, including those for review articles. No randomized controlled trials (RCTs) on balloon kyphoplasty were identified. All of the published studies were either prospective cohort studies or retrospective studies with no controls. Eleven studies (all case series) met the inclusion criteria. There was also a comparative study published in German that had been translated into English.
Summary of Findings
The results of the 1 comparative study (level 3a evidence) that was included in this review showed that, compared with conservative medical care, balloon kyphoplasty significantly improved patient outcomes.
Patients who had balloon kyphoplasty reported a significant reduction in pain that was maintained throughout follow-up (6 months), whereas pain scores did not change in the control group. Patients in the balloon kyphoplasty group did not need pain medication after 3 days. In the control group, about one-half of the patients needed more pain medication in the first 4 weeks after the procedure. After 6 weeks, 82% of the patients in the control group were still taking pain medication regularly.
Adjacent fractures were more frequent in the control group than in the balloon kyphoplasty group.
The case series reported on several important clinical outcomes.
Pain: Four studies on osteoporosis patients and 1 study on patients with multiple myeloma/primary cancers used the Visual Analogue Scale (VAS) to measure pain before and after balloon kyphoplasty. All of these studies reported that patients had significantly less pain after the procedure. This was maintained during follow-up. Two other studies on patients with osteoporosis also used the VAS to measure pain and found a significant improvement in pain scores; however, they did not provide follow-up data.
Vertebral body height: All 5 studies that assessed vertebral body height in patients with osteoporosis reported a significant improvement in vertebral body height after balloon kyphoplasty. One study had 1-year follow-up data for 26 patients. Vertebral body height was significantly better at 6 months and 1 year for both the anterior and midline measurements.
Two studies reported that vertebral body height was restored significantly after balloon kyphoplasty for patients with multiple myeloma or metastatic disease. In another study, the researchers reported complete height restoration in 9% of patients, a mean 56% height restoration in 60% of patients, and no appreciable height restoration in 31% of the patients who received balloon kyphoplasty.
Kyphosis correction: Four studies that assessed Cobb angle before and after balloon kyphoplasty in patients with osteoporosis found a significant reduction in degree of kyphosis after the procedure. In these studies, the differences between preoperative and postoperative Cobb angles were 3.4°, 7°, 8.8°, and 9.9°.
Only 1 study investigated kyphosis correction in patients with multiple myeloma or metastatic disease. The authors reported a significant improvement (5.2°) in local kyphosis.
Quality of life: Four studies used the Short Form 36 (SF-36) Health Survey Questionnaire to measure the quality of life in patients with osteoporosis after they had balloon kyphoplasty. A significant improvement in most of the domains of the SF-36 (bodily pain, social functioning, vitality, physical functioning, mental health, and role functioning) was observed in 2 studies. One study found that general health declined, although not significantly, and another found that role emotional declined.
Both studies that used the Oswestry Disability Index found that patients had a better quality of life after balloon kyphoplasty. In one study, this improvement was statistically significant. In another study, researchers found that quality of life after kyphoplasty improved significantly, as measured with the Roland-Morris Disability Questionnaire. Yet another study used a quality of life questionnaire and found that 62% of the patients that had balloon kyphoplasty had returned to normal activities, whereas 2 patients had reduced mobility.
To measure quality of life in patients with multiple myeloma or metastatic disease, one group of researchers used the SF-36 and found significantly better scores on bodily pain, physical functioning, vitality, and social functioning after kyphoplasty. However, the scores for general health, mental health, role physical, and role emotional had not improved. A study that used the Oswestry Disability Index reported that patients’ scores were better postoperatively and at 3 months follow-up.
These were the main findings on complications in patients with osteoporosis:
The bone cement leaked in 37 (6%) of 620 treated fractures.
There were no reports of neurological deficits.
There were no reports of pulmonary embolism due to cement leakage.
There were 6 cases of cardiovascular events in 362 patients:
3 (0.8%) patients had myocardial infarction.
3 (0.8%) patients had cardiac arrhythmias.
There was 1 (0.27%) case of pulmonary embolism due to deep venous thrombosis.
There were 20 (8.4%) cases of new fractures in 238 patients.
For patients with multiple myeloma or metastatic disease, these were the main findings:
The bone cement leaked in 12 (9.6%) of 125 procedures.
There were no reports of neurological deficits.
Economic Analysis
Balloon kyphoplasty requires anesthesia. Standard vertebroplasty requires sedation and an analgesic. Based on these considerations, the professional fees (Cdn) for each procedure is shown in Table 1.
Professional Fees for Standard Vertebroplasty and Balloon Kyphoplasty
Balloon kyphoplasty has a sizable device cost add-on of $3,578 (the device cost per case) that standard vertebroplasty does not have. Therefore, the up-front cost (i.e., physician’s fees and device costs) is $187 for standard vertebroplasty and $3,812 for balloon kyphoplasty. (All costs are in Canadian currency.)
There are also “downstream costs” of the procedures, based on the different adverse outcomes associated with each. This includes the risk of developing new fractures (21% for vertebroplasty vs. 8.4% for balloon kyphoplasty), neurological complications (3.9% for vertebroplasty vs. 0% for balloon kyphoplasty), pulmonary embolism (0.1% for vertebroplasty vs. 0% for balloon kyphoplasty), and cement leakage (26.5% for vertebroplasty vs. 6.0% for balloon kyphoplasty). Accounting for these risks, and the base costs to treat each of these complications, the expected downstream costs are estimated at less than $500 per case. Therefore, the expected total direct medical cost per patient is about $700 for standard vertebroplasty and $4,300 for balloon kyphoplasty.
Kyphon, the manufacturer of the inflatable bone tamps has stated that the predicted Canadian incidence of osteoporosis in 2005 is about 29,000. The predicted incidence of cancer-related vertebral fractures in 2005 is 6,731. Based on Ontario having about 38% of the Canadian population, the incidence in the province is likely to be about 11,000 for osteoporosis and 2,500 for cancer-related vertebral fractures. This means there could be as many as 13,500 procedures per year in Ontario; however, this is highly unlikely because most of the cancer-related fractures likely would be treated with medication. Given a $3,600 incremental direct medical cost associated with balloon kyphoplasty, the budget impact of adopting this technology could be as high as $48.6 million per year; however, based on data from the Provider Services Branch, about 120 standard vertebroplasties are done in Ontario annually. Given these current utilization patterns, the budget impact is likely to be in the range of $430,000 per year. This is because of the sizable device cost add-on of $3,578 (per case) for balloon kyphoplasty that standard vertebroplasty does not have.
Policy Considerations
Other treatments for osteoporotic VCFs are medical management and open surgery. In cases without neurological involvement, the medical treatment of osteoporotic VCFs comprises bed rest, orthotic management, and pain medication. However, these treatments are not free of side effects. Bed rest over time can result in more bone and muscle loss, and can speed the deterioration of the underlying condition. Medication can lead to altered mood or mental status. Surgery in these patients has been limited because of its inherent risks and invasiveness, and the poor quality of osteoporotic bones. However, it may be indicated in patients with neurological deficits.
Neither of these vertebral augmentation procedures eliminates the need for aggressive treatment of osteoporosis. Osteoporotic VCFs are often under-diagnosed and under-treated. A survey of physicians in Ontario (1) who treated elderly patients living in long-term care homes found that although these physicians were aware of the rates of osteoporosis in these patients, 45% did not routinely assess them for osteoporosis, and 26% did not routinely treat them for osteoporosis.
Management of the underlying condition that weakens the vertebral bodies should be part of the treatment plan. All patients with osteoporosis should be in a medical therapy program to treat the underlying condition, and the referring health care provider should monitor the clinical progress of the patient.
The main complication associated with vertebroplasty and balloon kyphoplasty is cement leakage (extravertebral or vascular). This may result in more patient morbidity, longer hospitalizations, the need for open surgery, and the use of pain medications, all of which have related costs. Extravertebral cement leakage can cause neurological complications, like spinal cord compression, nerve root compression, and radiculopathy. In some cases, surgery is required to remove the cement and release the nerve. The rate of cement leakage is much lower after balloon kyphoplasty than after vertebroplasty. Furthermore, the neurological complications seen with vertebroplasty have not seen in the studies of balloon kyphoplasty. Rarely, cement leakage into the venous system will cause a pulmonary embolism. Finally, compared with vertebroplasty, the rate of new fractures is lower after balloon kyphoplasty.
Diffusion – International, National, Provincial
In Canada, balloon kyphoplasty has not yet been funded in any of the provinces. The first balloon kyphoplasty performed in Canada was in July 2004 in Ontario.
In the United States, the technology is considered by some states as medically reasonable and necessary for the treatment of painful vertebral body compression fractures.
There is level 4 evidence that balloon kyphoplasty to treat pain associated with VCFs due to osteoporosis is as effective as vertebroplasty at relieving pain. Furthermore, the evidence suggests that it restores the height of the affected vertebra. It also results in lower fracture rates in other vertebrae compared with vertebroplasty, and in fewer neurological complications due to cement leakage compared with vertebroplasty. Balloon kyphoplasty is a reasonable alternative to vertebroplasty, although it must be reiterated that this conclusion is based on evidence from level 4 studies.
Balloon kyphoplasty should be restricted to facilities that have sufficient volumes to develop and maintain the expertise required to maximize good quality outcomes. Therefore, consideration should be given to limiting the number of facilities in the province that can do balloon kyphoplasty.
PMCID: PMC3387743  PMID: 23074451
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.  Risk factors predicting the new symptomatic vertebral compression fractures after percutaneous vertebroplasty or kyphoplasty 
European Spine Journal  2011;21(5):905-911.
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.
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.
The most important risk factors affecting NVCFs were osteoporosis and intervertebral discal cement leakage.
PMCID: PMC3337901  PMID: 22160212
Osteoporotic compression fracture; Vertebroplasty; Kyphoplasty; BMD; Discal leakage
5.  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.
PMCID: PMC3591824  PMID: 14505122
Vertebral compression fracture; Osteoporotic compression fracture; Percutaneous vertebroplasty; Vertebroplasty; Kyphoplasty
6.  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.
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.
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.
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.
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.
Treatment of post-vertebroplasty adjacent VCFs with teriparatide (no new vertebroplasty) was more effective than that of repeated vertebroplasties combined with an anti-resorber.
PMCID: PMC3332357  PMID: 21769661
Adjacent vertebral fracture; Antiresorptive agent; Teriparatide; Vertebral compression fracture; Vertebroplasty; Medicine & Public Health; Gynecology; Rheumatology; Orthopedics; Endocrinology
7.  The Incidence of New Vertebral Compression Fractures in Women after Kyphoplasty and Factors Involved 
Yonsei Medical Journal  2007;48(4):645-652.
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.
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.
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.
PMCID: PMC2628047  PMID: 17722237
Kyphoplasty; compression fracture; influencing factor
8.  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.
PMCID: PMC2711237  PMID: 19609423
Percutaneous vertebroplasty; Extreme multi-level vertebropklasty compression fracture
9.  Risk Factors of New Compression Fractures in Adjacent Vertebrae after Percutaneous Vertebroplasty 
Asian Spine Journal  2011;5(3):180-187.
Study Design
Retrospective study.
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.
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.
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).
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.
PMCID: PMC3159067  PMID: 21892391
Adjacent vertebral fractures; Percutaneous vertebroplasty; Risk factors
10.  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.
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.
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.
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.
PMCID: PMC2627204  PMID: 18838851
Osteoporosis; Vertebral compression fracture; Kyphoplasty
11.  Role of the supine lateral radiograph of the spine in vertebroplasty for osteoporotic vertebral compression fracture: a prospective study 
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.
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.
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.
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.
PMCID: PMC2918541  PMID: 20642815
12.  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.
PMCID: PMC2989275  PMID: 20559850
Osteoporotic vertebral compression fracture; Percutaneous kyphoplasty; Recompression; Intervertebral cleft; Non-PMMA-endplate-contact
13.  The Prognostic Factors Influencing on the Therapeutic Effect of Percutaneous Vertebroplasty in Treating Osteoporotic Vertebral Compression Fractures 
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.
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.
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.
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.
PMCID: PMC2640817  PMID: 19242566
Osteoporosis; Vertebral compression fracture; Vertebroplasty
14.  Is There Really No Benefit of Vertebroplasty for Osteoporotic Vertebral Fractures? A Meta-analysis 
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.
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.
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.
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.
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.
PMCID: PMC3442000  PMID: 22729693
15.  Vertebral compression fractures after spine irradiation using conventional fractionation in patients with metastatic colorectal cancer 
Radiation Oncology Journal  2014;32(4):221-230.
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.
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.
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.
PMCID: PMC4282996  PMID: 25568850
Spinal neoplasm; Compression fractures; Spinal fractures; Radiotherapy; Colorectal cancer; Risk factors
16.  Recompression in new levels after percutaneous vertebroplasty and kyphoplasty compared with conservative treatment 
Study design
A prospective clinical study assessing new vertebral compression fracture after previous treatment.
The purpose of this study was to investigate the incidence and associated risk factors of new symptomatic osteoporotic vertebral compression fractures (OVCFs) in patients treated by percutaneous vertebroplasty (PVP) and kyphoplasty (PKP) versus conservative treatment, and to elucidate our findings.
Summary of background data
There are a lot of reports concerning the feasibility and efficacy of this minimally invasive procedure compared with conservative treatment, especially in pain soothing. However, it is still unclear whether the risk of subsequent fracture has increased among operative treatment patients in the long term.
From November 2005 to July 2009, 290 consecutive patients with 363 OVCFs were randomly selected for PVP/PKP or conservative treatment and evaluated with a mean follow-up of 49.4 months (36–80 months). Some parameters were characterized and statistically compared in this study. Telephone questionnaires, clinical reexamine, and plain radiographs were performed in the follow-up.
Thirty-one of 290 (10.7 %) patients had experienced 42 newly developed symptomatic secondary OVCFs. Among 169 operation (53.3 % vertebroplasty, 46.7 % kyphoplasty) and 121 comparison patients, there is no significant statistical difference of new OVCFs incidence between the two groups calculated by patient proportion. However, in separate, the rate of secondary adjacent fractures calculated by vertebral refracture number is significantly higher than non-adjacent levels in PVP/PKP group but no significant statistical difference was observed in conservative group. The time interval of recompression after operative procedure was much shorter than that for comparison group (9.7 ± 17.8 versus 22.4 ± 7.99 months, p = 0.017). In addition, older age, gender, fracture times, location of original fracture segment, the amount of cement, cement leakage, operation modality (PVP or PKP),and initial number of OVCFs were documented, but these were not the influencing factors in this study (p > 0.05).
Patients who had experienced PVP/PKP were not associated with an increased risk of recompression in new levels. However, recompression in new levels of PVP/PKP group occurred much sooner than that of conservative group in the follow-up period. The incidence of new vertebral fractures observed at adjacent levels was substantially higher but no sooner than at distant levels in PVP/PKP group. No major risk factors involving new OVCFs have been found in this study and  augmentation for sandwich situation is not necessary.
PMCID: PMC3889698  PMID: 24287674
Percutaneous vertebroplasty; Kyphoplasty; Adjacent fracture; Conservative treatment
17.  Transpedicle body augmenter for vertebral augmentation in symptomatic multiple osteoporotic compression fractures 
Indian Journal of Orthopaedics  2010;44(2):191-197.
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).
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%.
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.
TpBA via a minimally invasive method led to early and medium-term clinical improvements and anatomic restoration of multiple symptomatic VCFs.
PMCID: PMC2856395  PMID: 20419007
Vertebral compression fracture; osteoporosis; transpedicle body augmenter
18.  Spinal loads after osteoporotic vertebral fractures treated by vertebroplasty or kyphoplasty 
European Spine Journal  2005;15(8):1255-1264.
Vertebroplasty and kyphoplasty are routine treatments for compression fractures of vertebral bodies. A wedge-shaped compression fracture shifts the centre of gravity of the upper body anteriorly and generally, this shift can be compensated in the spine and in the hips. However, it is still unclear how a wedge-shaped compression fracture of a vertebra increases forces in the trunk muscle and the intradiscal pressure in the adjacent discs. A nonlinear finite element model of the lumbar spine was used to estimate the force in the trunk muscle, the intradiscal pressure and the stresses in the endplates in the intact spine, and after vertebroplasty and kyphoplasty treatment. In this study, kyphoplasty represents a treatment with nearly full fracture reduction and vertebroplasty one without restoration of kyphotic angle although in reality kyphoplasty does not guarantee fracture reduction. If no compensation of upper body shift is assumed, the force in the erector spine increases by about 200% for the vertebroplasty but by only 55% for the kyphoplasty compared to the intact spine. Intradiscal pressure increases by about 60 and 20% for the vertebroplasty and kyphoplasty, respectively. In contrast, with shift compensation of the upper body, the increase in muscle force is much lower and increase in intradiscal pressure is only about 20 and 7.5% for the vertebroplasty and kyphoplasty, respectively. Augmentation of the vertebral body with bone cement has a much smaller effect on intradiscal pressure. The increase in that case is only about 2.4% for the intact as well as for the fractured vertebra. Moreover, the effect of upper body shift after a wedge-shaped vertebral body fracture on intradiscal pressure and thus on spinal load is much more pronounced than that of stiffness increase due to cement infiltration. Maximum von Mises stress in the endplates of all lumbar vertebrae is also higher after kyphoplasty and vertebroplasty. Cement augmentation has only a minor effect on endplate stresses in the unfractured vertebrae. The advantages of kyphoplasty found in this study will be apparent only if nearly full fracture reduction is achieved. Otherwise, differences between kyphoplasty and vertebroplasty become small or vanish. Our results suggest that vertebral body fractures in the adjacent vertebrae after vertebroplasty or kyphoplasty are not induced by the elevated stiffness of the treated vertebra, but instead the anterior shift of the upper body is the dominating factor.
PMCID: PMC3233952  PMID: 16311752
Cement augmentation; Vertebroplasty; Kyphoplasty; Finite-element modelling; Intradiscal pressure
19.  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).
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.
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.
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.
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.
PMCID: PMC3694101  PMID: 23840316
20.  Balloon kyphoplasty for the treatment of pathological vertebral compressive fractures 
European Spine Journal  2004;14(3):250-260.
Previous clinical studies have shown the safety and effectiveness of balloon kyphoplasty in the treatment of pathological vertebral compression fractures (VCFs). However, they have not dealt with the impact of relatively common comorbid conditions in this age group, such as spinal stenosis, and they have not explicitly addressed the use of imaging as a prognostic indicator for the restoration of vertebral body height. Neither have these studies dealt with management and technical problems related to surgery, nor the effectiveness of bone biopsy during the same surgical procedure. This is a prospective study comparing preoperative and postoperative vertebral body heights, kyphotic deformities, pain intensity (using visual analogue scale) and quality of life (Oswestry disability questionnaire) in patients with osteoporotic vertebral compression fractures (OVCFs) and osteolytic vertebral tumors treated with balloon kyphoplasty.
Thirty-two consecutive patients, 27 OVCFs (49 vertebral bodies [VBs]) and 5 patients suffering from VB tumor (12 VBs) were treated by balloon kyphoplasty. The mean age was 68.2 years. All patients were assessed within the first week of surgery, and then followed up after one, three and six months; all patients (27 OVCFs and 5 tumor patients) were followed up for 12 months, 17 patients (14 OVCFs and 3 tumors) were followed up for 18 months and 9 patients (8 OVCFs and 1 tumor) were followed up for 24 months (mean follow up 18 months). The correction of kyphosis and vertebral heights were measured by comparing preoperative and postoperative radiographic measurements.
Thirty-one patients (96.9%) exhibited significant and immediate pain improvement: 90% responded within 24 h and 6.3% responded within 5 days. Daily activities improved by 53% on the Oswestry scale. In the OVCF group, kyphosis correction was achieved in 24/27 patients (89.6%) with a mean correction of 7.6°. Anterior wall height was restored in 43/49 VBs (88%) (mean increment of 4.3 mm), and mid vertebral body height was restored in 45/49 VBs (92%) (mean increment of 4.8 mm). Edema (high intensity signal) on short tau inversion recovery (STIR) was evidenced in all OVCF patients who experienced symptoms for less than nine months and was associated with correction of deformity. Cement leakage was the only technical problem encountered; it occurred in 5/49 VBs (10.2%) of the osteoporotic group and 1/12 VBs (8.3%) of the tumor group but had no clinical consequences. The incidence of leakage to the anterior epidural space was 2%. Spinal stenosis was present in three patients (11.1%) who responded successfully to subsequent laminectomy. Retrieval of tissue samples for biopsy was successful in 10/15 cases (67%). New fractures occurred in the adjacent level in 2/27 OVCF patients (7.4%).
Associated spinal stenosis with OVCF should not be overlooked; STIR MRI is a good predictor of deformity correction with balloon kyphoplasty. The prevalence of a new OVCF in the adjacent level is low.
PMCID: PMC3476745  PMID: 15480827
Kyphoplasty; PMMA; Osteoporotic vertebral compression fractures; Spinal stenosis; Laminectomy; STIR MRI; Biopsy
21.  Percutaneous balloon kyphoplasty for the treatment of vertebral compression fractures 
BMC Surgery  2014;14:3.
Vertebral compression fractures (VCFs) constitute a major health care problem, not only because of their high incidence but also because of their direct and indirect negative impacts on both patients’ health-related quality of life and costs to the health care system. Two minimally invasive surgical approaches were developed for the management of symptomatic VCFs: balloon kyphoplasty and vertebroplasty. The purpose of this study was to evaluate the effectiveness and safety of balloon kyphoplasty in the treatment of symptomatic VCFs.
Between July 2011 and June 2012, one hundred and eighty-seven patients with two hundred and fifty-one vertebras received balloon kyphoplasty in our hospital. There were sixty-five male and one hundred and twenty-two female patients with an average age of 74.5 (range, 61 to 95 years). The pain symptoms and quality of life, were measured before operation and at one day, three months, six months and one year following kyphoplasty. Radiographic data including restoration of kyphotic angle, anterior vertebral height, and any leakage of cement were defined.
The mean visual analog pain scale decreased from a preoperative value of 7.7 to 2.2 at one day (p < .05) following operation and the Oswestry Disability Index improved from 56.8 to 18.3 (p < .05). The kyphotic angle improved from a mean of 14.4° before surgery to 6.7° at one day after surgery (p < .05). The mean anterior vertebral height increased significantly from 52% before surgery to 74.5% at one day after surgery (p < .05) and 70.2% at one year follow-up. Minor cement extravasations were observed in twenty-nine out of two hundred and fifty-one procedures, including six leakage via basivertebral vein, three leakage via segmental vein and twenty leakage through a cortical defect. None of the leakages were associated with any clinical consequences.
Balloon kyphoplasty not only rapidly reduced pain and disability but also restored sagittal alignment in our patients at one-year follow-up. The treatment of osteoporotic vertebral compression fractures with balloon kyphoplasty is a safe, effective, and minimally invasive procedure that provides satisfactory clinical results.
PMCID: PMC3922728  PMID: 24423182
22.  Vertebroplasty and Kyphoplasty Are Associated with an Increased Risk of Secondary Vertebral Compression Fractures A Population-based Cohort Study 
Predominantly uncontrolled studies suggest that there may be a greater risk of subsequent vertebral compression fractures (VCFs) associated with vertebroplasty and kyphoplasty. To further understand the risk of VCFs, we conducted a population-based retrospective cohort study using data from a large regional health insurer.
Materials and Methods
Administrative claims procedure codes were used to identify a treatment group of patients receiving either a vertebroplasty or kyphoplasty (treatment group) and a comparison group of patients with a primary diagnosis of VCF who did not receive treatment during the same time period. The main outcomes of interest, validated by two independent medical record reviewers and adjudicated by a physician panel, were any new VCFs within: 1) 90-days; 2) 360-days; and 3) at adjacent vertebral levels. Multivariable logistic regression examined the association of vertebroplasty/kyphoplasty with new VCFs.
Among 48 treatment (51% vertebroplasty, 49% kyphoplasty) and 164 comparison patients, treated patients had a significantly greater risk of secondary VCFs than comparison patients for fractures within 90 days of the procedure or comparison group time point (adjusted odds ratio (OR) = 6.3; 95% confidence interval (CI) 1.7 – 23.0) and within 360 days (adjusted OR = 3.1; 95% CI:1.1 – 8.4). Vertebroplasty and kyphoplasty were associated with a significantly greater rate of adjacent-level fractures as well.
Patients who had undergone vertebroplasty and kyphoplasty had a greater risk of new VCFs compared to patients with prior VCFs who did not undergo either procedure.
PMCID: PMC4089886  PMID: 18797812
23.  Results, experience and technical points learnt with use of the SKy Bone Expander kyphoplasty system for osteoporotic vertebral compression fractures: a prospective study of 40 patients with a minimum of 12 months of follow-up 
European Spine Journal  2007;16(11):1944-1950.
To describe our centre’s results, experience and technical points learnt with the SKy Bone Expander System for osteoporotic vertebral compression fractures (VCFs). Forty consecutive patients with painful single level T12 or L1 osteoporotic VCF who had failed conservative management for more than 3 months had 40 single level SKy Bone Expander kyphoplasties performed. Using local anaesthesia with patients in a prone, hyper-lordotic position, a unilateral, percutaneous, intra-pedicular approach was employed. Once correctly positioned, the SKy Bone Expander was expanded, creating a void. It was subsequently contracted, removed and bone cement injected. Pre-kyphoplasty and 12-month post-kyphoplasty radiological and functional outcomes were recorded. Statistical analysis was by Wilcoxon Signed Ranks Test. Median percentage increase in anterior, middle and posterior vertebral body heights at 12-month post-operative was 51.25% [inter-quartile range (IQR) 17.21–93.22], 52.29% (IQR 26.50–126.17) and 9.84% (IQR 4.94–19.26) respectively, while median percentage decrease in kyphotic angle was 30.77% (IQR 17.06–46.61). There was no significant vertebral body correction loss at 12-month post-operative. Visual analogue score, North American Spine Society and Short Form-36 scores for physical functioning and bodily pain scores improved by medians of 5.0 (IQR 3.0–8.0), 1.45 (IQR 0.68–2.90), 20.5 (IQR 0.0–40.8) and 10.0 (IQR 0.0–20.0) respectively. All P-values were <0.001. There were eight adjacent/remote level VCFs, three cases of cement extravasation and one case of the SKy Bone Expander being unable to be contracted and withdrawn from the vertebral body. It was left in situ. This is the first reported incidence of such a complication. The SKy Bone Expander System appears to be a viable alternative to balloon tamp kyphoplasty. Important technical considerations include proper device positioning within the vertebral body before expansion, single use of devices, familiarity with salvage procedure and injection of bone cement under close image intensifier guidance to prevent cement extravasation.
PMCID: PMC2223354  PMID: 17659364
Kyphoplasty; SKy Bone Expander; Vertebral compression fracture; Osteoporosis
24.  Applications of memory alloy stent in vertebral fractures 
The aim of this study was to evaluate the feasibility of treating vertebral compression fractures using an autonomously developed nitinol memory alloy vertebral stent.
Thoracolumbar vertebral specimens from adult human cadavers were made into models of compression fractures. The models were divided into group A, which received percutaneous kyphoplasty (PKP), balloon dilation, and nitinol memory alloy vertebral stent implantation (PKP + nitinol stent group); group B, which received percutaneous vertebroplasty (PVP) and direct implantation of a nitinol memory alloy vertebral stent (PVP + nitinol stent group); and group C, which received PKP, balloon dilation, and bone cement vertebroplasty (PKP + polymethylmethacrylate (PMMA) group). Vertebral heights were measured before and after the surgery and the water bath incubation to compare the impact of the 3 different surgical approaches on reducing vertebral compression.
The 3 surgical groups could all significantly restore the heights of compressed vertebral bodies. The vertebral heights of the PKP + nitinol stent group, PVP + nitinol stent group, and PKP + PMMA group were changed from the preoperative levels of (1.59±0.08) cm, (1.68±0.08) cm, and (1.66±0.11) cm to the postoperative levels of (2.00±0.09) cm, (1.87±0.04) cm, and (1.99±0.09) cm, respectively. After the water bath, the vertebral heights of each group were changed to (2.10±0.07) cm, (1.98±0.09) cm, and (2.00±0.10) cm, respectively. Pairwise comparison of the differences between the preoperative and postoperative vertebral heights showed that group A and group B differed significantly (P=0.000); group B and group C differed significantly (P=0.003); and group A and group C had no significant difference (P=0.172). Pairwise comparison of the differences in the vertebral heights before and after the water bath showed that group A and group C differed significantly (P=0.000); group B and group C differed significantly (P=0.000); and group A and group B had no significant difference (P=0.157).
The nitinol memory alloy stents can effectively support and reduce the compression of vertebral endplates and can be used to treat vertebral compression fractures without neurological symptoms.
PMCID: PMC4049948  PMID: 24869792
Alloys; Spine; Kyphoplasty
25.  Histological evaluation of bone biopsy results during PVP or PKP of vertebral compression fractures 
Oncology Letters  2012;5(1):135-138.
Percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP) is utilized for the treatment of vertebral compression fractures (VCFs). The present study was conducted to evaluate biopsy results obtained from VCFs during PVP or PKP. Between January 2003 and December 2011, 692 vertebral body biopsies were obtained from 546 patients (442 females and 104 males; mean age, 72.3 years), who underwent PVP or PKP for treatment of VCFs. A history of malignancy was identified in 44 patients. Histological/immunohistochemical evaluations were performed by experienced pathologists and 89.9% of biopsies obtained from 546 patients were suitable for histological/immunohistochemical evaluation. The biopsy results of 398 patients were in good agreement with the diagnosis of osteoporotic VCFs. Among the 44 patients with a history of malignancy, malignancy was identified in 25 patients, while osteoporosis was identified in 16 patients. Biopsies of the other 3 patients were not suitable for pathological examination. There were only 2 patients with previously undiagnosed malignancy. One patient was diagnosed with multiple myeloma, while another patient was diagnosed with metastatic carcinoma. In the present study, the rate of unsuspected malignancy was 0.4%. No symptomatic complications occurred as a result of biopsy. The results indicate that biopsy is safely performed during PVP or PKP and it is an efficacious procedure that verifies the pathological process and assists in identifying previously unsuspected processes responsible for VCFs. We recommend obtaining the biopsy of every collapsed vertebral body during PVP or PKP procedures.
PMCID: PMC3525491  PMID: 23255908
vertebral compression fractures; percutaneous vertebroplasty; percutaneous kyphoplasty; biopsy

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