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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.  Early clinical outcome and complications related to balloon kyphoplasty 
Orthopedic Reviews  2012;4(2):e25.
The treatment of painful osteoporotic vertebral compression fractures using transpedicular cement augmentation has grown significantly over the last two decades. The benefits of balloon kyphoplasty compared to conservative treatment remain controversial and are discussed in the literature. The complication rates of vertebroplasty and kyphoplasty are considered to be low. The focus of this study was the analysis of acute and clinically relevant complications related to this procedure. In our department, all patients treated between February 2002 and February 2011 with percutaneous cement augmentation (372 patients, 522 augmented vertebral bodies) were prospectively recorded. Demographic data, comorbidities, fracture types, intraoperative data and all complications were documented. The pre- and postoperative pain-level and neurological status (Frankel-Score) were evaluated. All patients underwent a standardized surgical procedure. Two hundred and ninety-seven patients were treated solely by balloon kyphoplasty; 216 females (72.7%) and 81 males (27.3%). Average patient age was 76.21 years (±10.71, range 35–98 years). Average American Society Anestesiologists score was 3.02. According to the Orthopedic Trauma Association classification, there were 69 A 1.1 fractures, 177 A 1.2 fractures, 178 A 3.1.1 fractures and 3 A 3.1.3 fractures. Complications were divided into preoperative, intraoperative and postoperative events. There were 4 preoperative complications: 3 patients experienced persistent pain after the procedure. In one case, the pedicles could not be visualized during the procedure and the surgery was terminated. One hundred and twenty-nine (40.06%) of the patients showed intraoperative cement leaking outside the vertebras, one severe hypotension and tachycardia as reaction to the inflation of the balloons, and there was one cardiac arrest during surgery. Postoperative subcutaneous hematomas were observed in 3 cases, 13 patients developed a urinary tract infection, and 2 patients died during hospitalization. Twenty-four patients (8.1%) returned because of new pain events and 23 patients reported a new painful fracture. Balloon kyphoplasty is a save and effective procedure to treat patients with painful vertebral compression fractures. Rapid patient mobilization after kyphoplasty, as well as a prompt reintegration into the social environment, are possible. Compared to other surgical procedures, especially in patients with an average age of 75 years, balloon kyphoplasty seems to offer some advantages. However, the procedure still has a potential for serious complications and should be performed by well trained personnel.
doi:10.4081/or.2012.e25
PMCID: PMC3395994  PMID: 22802993
balloon kyphoplasty; outcome; complications; vertebral compression fractures.
4.  The Role of Bone Cement Augmentation in the Treatment of Chronic Symptomatic Osteoporotic Compression Fracture 
Objective
Bone cement augmentation procedures such as percutaneous vertebroplasty and balloon kyphoplasty have been shown to be effective treatment for acute or subacute osteoporotic vertebral compression fractures. The purpose of this study was to determine the efficacy of bone cement augmentation procedures for long standing osteoporotic vertebral compression fracture with late vertebral collapse and persistent back pain.
Methods
Among 278 single level osteoporotic vertebral compression fractures that were treated by vertebral augmentation procedures at our institute, 18 consecutive patients were included in this study. Study inclusion was limited to initially, minimal compression fractures, but showing a poor prognosis due to late vertebral collapse, intravertebral vacuum clefts and continuous back pain despite conservative treatment for more than one year. The subjects included three men and 15 women. The mean age was 70.7 with a range from 64 to 85 years of age. After postural reduction for two days, bone cement augmentation procedures following intraoperative pressure reduction were performed. Imaging and clinical findings, including the level of the vertebra involved, vertebral height restoration, injected cement volume, local kyphosis, clinical outcome and complications were analyzed.
Results
The mean follow-up period after bone cement augmentation procedures was 14.3 months (range 12-27 months). The mean injected cement volume was 4.1 mL (range 2.4-5.9 mL). The unipedicular approach was possible in 15 patients. The mean pain score (visual analogue scale) prior to surgery was 7.1, which decreased to 3.1 at 7 days after the procedure. The pain relief was maintained at the final follow up. The kyphotic angle improved significantly from 21.2 ± 4.9° before surgery to 10.4 ± 3.8° after surgery. The fraction of vertebral height increased from 30% to 60% after bone cement augmentation, and the restored vertebral height was maintained at the final follow up. There were no serious complications related to cement leakage.
Conclusion
In the management of even long-standing osteoporotic vertebral compression fracture for over one year, bone cement augmentation procedures following postural reduction were considered safe and effective treatment in cases of non-healing evidence.
doi:10.3340/jkns.2010.48.6.490
PMCID: PMC3053542  PMID: 21430974
Long standing; Compression fracture; Osteoporosis; Bone cement
5.  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
6.  Treatment of acute thoracolumbar burst fractures with kyphoplasty and short pedicle screw fixation: Transpedicular intracorporeal grafting with calcium phosphate: A prospective study 
Indian Journal of Orthopaedics  2007;41(4):354-361.
Background:
In the surgical treatment of thoracolumbar fractures, the major problem after posterior correction and transpedicular instrumentation is failure to support the anterior spinal column, leading to loss of correction and instrumentation failure with associated complaints. We conducted this prospective study to evaluate the outcome of the treatment of acute thoracolumbar burst fractures by transpedicular balloon kyphoplasty, grafting with calcium phosphate cement and short pedicle screw fixation plus fusion.
Materials and Methods:
Twenty-three consecutive patients of thoracolumbar (T9 to L4) burst fracture with or without neurologic deficit with an average age of 43 years, were included in this prospective study. Twenty-one from the 23 patients had single burst fracture while the remaining two patients had a burst fracture and additionally an adjacent A1-type fracture. On admission six (26%) out of 23 patients had neurological deficit (five incomplete, one complete). Bilateral transpedicular balloon kyphoplasty with liquid calcium phosphate to reduce segmental kyphosis and restore vertebral body height and short (three vertebrae) pedicle screw instrumentation with posterolateral fusion was performed. Gardner kyphosis angle, anterior and posterior vertebral body height ratio and spinal canal encroachment were calculated pre- to postoperatively.
Results:
All 23 patients were operated within two days after admission and were followed for at least 12 months after index surgery. Operating time and blood loss averaged 45 min and 60 cc respectively. The five patients with incomplete neurological lesions improved by at least one ASIA grade, while no neurological deterioration was observed in any case. The VAS and SF-36 (Role physical and Bodily pain domains) were significantly improved postoperatively. Overall sagittal alignment was improved from an average preoperative 16° to one degree kyphosis at final followup observation. The anterior vertebral body height ratio improved from 0.6 preoperatively to 0.9 (P<0.001) postoperatively, while posterior vertebral body height improved from 0.95 to 1 (P<0.01). Spinal canal encroachment was reduced from an average 32% preoperatively to 20% postoperatively. Cement leakage was observed in four cases (three anterior to vertebral body and one into the disc without sequalae). In the last CT evaluation, there was a continuity between calcium phosphate and cancellous vertebral body bone. Posterolateral radiological fusion was achieved within six months after index operation. There was no instrumentation failure or measurable loss of sagittal curve and vertebral height correction in any group of patients.
Conclusions:
Balloon kyphoplasty with calcium phosphate cement secured with posterior short fixation in the thoracolumbar spine provided excellent immediate reduction of posttraumatic segmental kyphosis and significant spinal canal clearance and restored vertebral body height in the fracture level.
doi:10.4103/0019-5413.37000
PMCID: PMC2989509  PMID: 21139791
Balloon kyphoplasty; calcium phosphate; neurological deficit; pedicle screw; short internal fixation; thoracolumbar vertebral fracture; transpedicular grafting
7.  Segmental Deformity Correction after Balloon Kyphoplasty in the Osteoporotic Vertebral Compression Fracture 
Objective
Balloon kyphoplasty can effectively relieve the symptomatic pain and correct the segmental deformity of osteoporotic vertebral compression fractures. While many articles have reported on the effectiveness of the procedure, there has not been any research on the factors affecting the deformity correction. Here, we evaluated both the relationship between postoperative pain relief and restoration of the vertebral height, and segmental kyphosis, as well as the various factors affecting segmental deformity correction after balloon kyphoplasty.
Methods
Between January 2004 and December 2006, 137 patients (158 vertebral levels) underwent balloon kyphoplasty. We analyzed various factors such as the age and sex of the patient, preoperative compression ratio, kyphotic angle of compressed segment, injected PMMA volume, configuration of compression, preoperative bone mineral density (BMD) score, time interval between onset of symptom and the procedure, visual analogue scale (VAS) score for pain rating and surgery-related complications.
Results
The mean postoperative VAS score improvement was 4.93±0.17. The mean postoperative height restoration rate was 17.8±1.57% and the kyphotic angle reduction was 1.94±0.38°. However, there were no significant statistical correlations among VAS score improvement, height restoration rate, and kyphotic angle reduction. Among the various factors, the configuration of the compressed vertebral body (p=0.002) was related to the height restoration rate and the direction of the compression (p=0.006) was related with the kyphotic angle reduction. The preoperative compression ratio (p=0.023, p=0.006) and injected PMMA volume (p<0.001, p=0.035) affected both the height restoration and kyphotic angle reduction. Only the preoperative compression ratio was found to be as an independent affecting factor (95% CI : 1.064-5.068).
Conclusion
The two major benefits of balloon kyphoplasty are immediate pain relief and local deformity correction, but segmental deformity correction achieved by balloon kyphoplasty does not result in additional pain relief. Among the factors that were shown to affect the segmental deformity correction, configuration of the compressed vertebral body, direction of the most compressed area, and preoperative compression ratio were not modifiable. However, careful preoperative consideration about the modifiable factor, the PMMA volume to inject, may contribute to the dynamic correction of the segmental deformity.
doi:10.3340/jkns.2007.42.5.371
PMCID: PMC2588189  PMID: 19096572
Balloon kyphoplasty; Compression fracture; Deformity; Restoration
8.  Balloon kyphoplasty for the treatment of pathological vertebral compressive fractures 
European Spine Journal  2004;14(3):250-260.
Background
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.
Methods
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.
Results
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%).
Conclusions
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.
doi:10.1007/s00586-004-0767-4
PMCID: PMC3476745  PMID: 15480827
Kyphoplasty; PMMA; Osteoporotic vertebral compression fractures; Spinal stenosis; Laminectomy; STIR MRI; Biopsy
9.  The role of kyphoplasty in the management of osteogenesis imperfecta: risk or benefit? 
European Spine Journal  2009;19(Suppl 2):144-148.
Kyphoplasty is a recognized treatment option in the management of symptomatic osteoporotic compression fractures, osteolytic vertebral metastases or haemangioma. To our knowledge, kyphoplasty with polymethylmethacrylate in a patient with type I osteogenesis imperfecta (OI) and a vertebral compression fracture has not been reported so far. We report on a 58-year-old patient with type I OI and a vertebral compression fracture at L2 with undislocated posterior vertebral wall and an additional older L1 fracture. Because of severe back pain resistant to conservative therapy over 5 months the indication for percutaneous kyphoplasty was made. Preoperative adjacent endplates of L2 were nearly parallel. Radiologically a minimal loss of height of the L2 vertebra was seen without adjacent fractures at 9 months follow-up. A slight increase of the preoperative kyphotic angle of overlying vertebrae L1 (8.7°/10.3°) and T12 (10.4°/11.0°) was apparent. The visual analogue scale showed decrease of low back pain from 10 to 2 allowing mobilization with a walking frame. Kyphoplasty constitutes a minimal invasive therapeutic alternative in the treatment of vertebral fractures in type I OI and pain, resistant to conservative treatment. Similar to the results of osteoporotic fractures the immediate reduction of pain and stabilization of the fracture in undislocated fragments can be achieved. No adjacent fractures occurred 9 months postoperatively after kyphoplasty in type I OI. Preoperative parallelism of the endplates seems to protect from adjacent fractures.
doi:10.1007/s00586-009-1197-0
PMCID: PMC2899639  PMID: 19949821
Osteogenesis imperfecta; Kyphoplasty; Compression fracture; Polymethylmethacrylate; Spine
10.  Percutaneous kyphoplasty combined with the posterior screw-rod system in treatment of osteoporotic thoracolumbar fractures 
Indian Journal of Orthopaedics  2013;47(3):230-233.
Background:
The osteoporotic vertebral compression fractures (OVCF) have attracted more and more attention due to increase in life span globally and aging population. Percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) have been popularized rapidly by virtue of their unique advantage in minimal invasiveness. We analysed our results in osteoporotic thoracolumbar fractures using percutaneous kyphoplasty and posterior screw rod system. To investigate the possibility of treatment of rupture of the posterior vertebral osteoporotic fractures by means of kyphoplasty combined with the posterior screw-rod system.
Materials and Methods:
Twenty six patients (65 years of age or older) with the single spine fractures included in study. The preoperative bone mineral density was measured by dual-energy X-ray. The PKP was done in all the cases. Decompression was done if neurological symptoms were present.
Results:
The results demonstrated osteoporosis with BMD T value ≤ −2.5; injured posterior vertebral body (3 cases) had shown the whole damage accompanied by neurological symptoms through X-ray or CT. After 2 days, the remaining patients of back pain symptoms were relieved or disappeared except for three cases of patients with decompression incision. VAS score and Cobb angle changed from preoperative 8.23 ± 0.17 and 28.7 ± 0.33° respectively to postoperative 3.77 ± 0.44 and 3.8 ± 0.2° respectively.
Conclusion:
Treatment of rupture of the posterior vertebral osteoporotic thoracolumbar fractures by means of kyphoplasty combined with posterior screw-rod system is a safe, effective procedure.
doi:10.4103/0019-5413.111496
PMCID: PMC3687897  PMID: 23798751
Kyphoplasty; osteoporotic fractures; thoracolumbar fractures; screw rod system
11.  Kyphoplasty versus vertebroplasty for painful osteoporotic vertebral compression fractures—which one is better? A systematic review and meta-analysis 
Background
Whether kyphoplasty or vertebroplasty is better for painful osteoporotic vertebral compression fracture is a widely debated issue. Studies on the comparison of the 2 approaches are relative limited and a wide variation exists in the patient population, study design, and results. These factors make it difficult for workers in this field to know the exact value of the 2 approaches.
Objective
To perform a systematic review and meta-analysis to compare the clinical outcomes and complications of kyphoplasty versus vertebroplasty for painful osteoporotic vertebral compression fractures (OVCF).
Study design
A systematic review and meta-analysis.
Methods
MEDLINE, EMBASE, and other databases were searched for all the relevant original articles published from January 1987 to September 2012 comparing kyphoplasty with vertebroplasty for painful OVCF. The following outcomes were mainly evaluated: visual analog scale (VAS), vertebral height, kyphosis angle, new vertebral fractures, and cement leakage.
Results
A total of 15 articles fulfilled all the inclusion criteria. The baseline characteristics such as sex, age, and number of prevalent fractures were comparable for both groups (P > .05). VAS score for the kyphoplasty group was significantly more than that for the vertebroplasty group at 1-3 days, 3 months, 6 months, 1 year, and 2 years after surgery (P < .05). Vertebral height in the kyphoplasty group was significantly higher than the vertebroplasty group at 3 months, 6 months, and 2 years (P < 0.05). Kyphosis angle in the kyphoplasty group was significantly lower at 3 months, 6 months, and 2 years (P < 0.05). The occurrence of new vertebral fractures in the kyphoplasty group had no significant difference with the vertebroplasty group at 3 months, 6 months, and 2 years (P > 0.05). The occurrence of cement leakage was significantly lower in the vertebroplasty group (P < 0.05).
Limitations
The main limitations of this review are that the demographics and comorbidities of study participants were not reported. These possible sources of heterogeneity could not be examined.
Conclusions
Percutaneous kyphoplasty is better than vertebroplasty in the treatment of painful OVCF. Kyphoplasty had better improvement at VAS score, vertebral height, and kyphosis angle with lower occurrence of cement leakage.
doi:10.1016/j.ijsp.2013.03.001
PMCID: PMC4300972
Vertebroplasty; Kyphoplasty; OVCF; META
12.  Reduction of the domino effect in osteoporotic vertebral compression fractures through short-segment fixation with intravertebral expandable pillars compared to percutaneous kyphoplasty: a case control study 
Background
Osteoporotic vertebral compression fracture is the leading cause of disability and morbidity in elderly people. Treatment of this condition remains a challenge. Osteoporotic vertebral compression fractures can be managed with various approaches, but each has limitations. In this study, we compared the clinical outcomes obtained using short-segment fixation with intravertebral expandable pillars (I-VEP) to those obtained with percutaneous kyphoplasty in patients who had suffered vertebral compression fractures.
Methods
The study included 46 patients with single-level osteoporotic thoracolumbar fractures. Twenty-two patients in Group I underwent short-segment fixation with I-VEP and 24 patients in Group II underwent kyphoplasty. All patients were evaluated pre- and postoperatively using a visual analogue scale, anterior height of the fractured vertebra, and kyphotic angle of the fractured vertebra. The latter 2 radiological parameters were measured at the adjacent segments as well.
Results
There was no significant difference between the groups in terms of gender or fracture level, but the mean age was greater in Group II patients (p = 0.008). At the 1-year follow-up, there were no significant differences in the visual analogue scale scores, anterior height of the fractured vertebra, or the value representing anterior height above the fractured vertebra and kyphotic angle below the fractured vertebra, after adjusting for the patients’ gender, fracture level, and age. When considered separately, the anterior height below the fractured vertebra was significantly higher and the kyphotic angle above the fractured vertebra was significantly smaller in Group I than in Group II (p = 0.029 and p = 0.008, respectively). The kyphotic angle of the fractured vertebra was significantly smaller in Group II than in Group I (p < 0.001).
Conclusions
In older individuals with vertebral compression fractures, kyphoplasty restored and maintained the collapsed vertebral body with less kyphotic deformity than that induced by short-segment fixation with I-VEP. Short-segment fixation with I-VEP was more effective in maintaining the integrity of adjacent segments, which prevented the domino effect often observed in patients with osteoporotic kyphotic spines.
doi:10.1186/1471-2474-14-75
PMCID: PMC3598560  PMID: 23452614
Short-segment fixation; Intravertebral expandable pillar; Percutaneous kyphoplasty; Vertebral compression fracture
13.  Safety, effectiveness and predictors for early reoperation in therapeutic and prophylactic vertebroplasty: short-term results of a prospective case series of patients with osteoporotic vertebral fractures 
European Spine Journal  2011;21(Suppl 6):792-799.
Introduction
Vertebroplasty (VP) is a cost-efficient alternative to kyphoplasty; however, regarding safety and vertebral body (VB) height restoration, it is considered inferior. We assessed the safety and efficacy of VP in alleviating pain, improving quality of life (QoL) and restoring alignment.
Methods
In a prospective monocenter case series from May 2007 until July 2008, there were 1,408 vertebroplasties performed during 319 interventions in 306 patients with traumatic, lytic and osteoporotic fractures. The 249 interventions in 233 patients performed because of osteoporotic vertebral fractures were analyzed regarding demographics, treatment and radiographic details, pain alleviation (VAS), QoL improvement (NASS and EQ-5D), complications and predictors for new fractures requiring a reoperation.
Results
The osteoporotic patient sample consisted of 76.7% (179) females with a median age of 80 years. A total of 54 males had a median age of 77 years. On average, there were 1.8 VBs fractured and 5 VBs treated. The preoperative pain was assessed by the visual analog scale (VAS) and decreased from 54.9 to 40.4 pts after 2 months and 31.2 pts after 6 months. Accordingly, the QoL on the EQ-5D measure (−0.6 to 1) improved from 0.35 pts before surgery to 0.56 pts after 2 and to 0.68 pts after 6 months. The preoperative Beck Index (anterior height/posterior height) improved from a mean of 0.64 preoperative to 0.76 postoperative, remained stable at 2 months and slightly deteriorated to 0.72 at 6 months postoperatively. There were cement leakages in 26% of the fractured VBs and in 1.4% of the prophylactically cemented VBs; there were symptoms in 4.3%, and most of them were temporary hypotension and one pulmonary cement embolism that remained asymptomatic. The univariate regression model revealed a tendency for a reduced risk for new or refractures on radiographs (OR = 2.61, 95% CI 0.92–7.38, p = 0.12) and reoperations (OR = 2.9, 95% CI 0.94–8.949, p = 0.1) when prophylactic augmentation was performed. The final multivariate regression model revealed male patients to have an about three times higher refracture risk (radiographic) (OR = 2.78, p = 0.02) at 6 months after surgery. Patients with a lumbar index fracture had an about three to five times higher refracture/reoperation risk than patients with a thoracic (OR = 0.33/0.35, p = 0.009/0.01) or thoracolumbar (OR = 0.32/0.22, p = 0.099/0.01) index fracture.
Conclusion
If routinely used, VP is a safe and efficacious treatment option for osteoporotic vertebral fractures with regard to pain relief and improvement of the QoL. Even segmental realignment can be partially achieved with proper patient positioning. Certain patient or fracture characteristics increase the risk for early radiographic refractures or new fractures, or a reoperation; a consequent prophylactic augmentation showed protective tendencies, but the study was underpowered for a final conclusion.
doi:10.1007/s00586-011-1989-x
PMCID: PMC3535211  PMID: 21877131
Osteoporosis; Percutaneous vertebroplasty; Vertebral fractures; Prophylactic augmentation
14.  Percutaneous balloon kyphoplasty for the treatment of vertebral compression fractures 
BMC Surgery  2014;14:3.
Background
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.
Methods
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.
Results
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.
Conclusions
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.
doi:10.1186/1471-2482-14-3
PMCID: PMC3922728  PMID: 24423182
15.  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.
doi:10.1007/s00586-007-0438-3
PMCID: PMC2223354  PMID: 17659364
Kyphoplasty; SKy Bone Expander; Vertebral compression fracture; Osteoporosis
16.  Percutaneous balloon kyphoplasty of osteoporotic vertebral compression fractures with intravertebral cleft 
Indian Journal of Orthopaedics  2014;48(1):53-59.
Background:
Intravertebral cleft is a structural change in osteoporotic vertebral compression fractures (OVCF), which is the manifestation of ischemic vertebral osteonecrosis complicated with fracture nonunion and pseudoarthrosis and appears in the late stage of OVCF. Despite numerous studies on OVCF, few aim to evaluate the clinicoradiological characteristics and clinical significance of intravertebral cleft in OVCF. This study investigates clinicoradiological characteristics of intravertebral cleft in OVCF and the effect on the efficacy of percutaneous balloon kyphoplasty (PKP).
Materials and Methods:
PKP was performed on 139 OVCF patients without intravertebral cleft (group A) and 44 OVCF patients with intravertebral cleft (group B). The frequency distribution of the affected vertebral body, bone cement infusion volume, imaging manifestation, leakage rate and type, preoperative and postoperative height of the affected vertebral body, visual analog scale (VAS) and Oswestry disability index (ODI) score were evaluated.
Results:
Significant differences were found in the frequency distribution of the affected vertebral body and bone cement leakage type between the two groups (P < 0.05). However, differences in bone cement infusion volume and leakage rate (P > 0.05) were not detected. In both groups, the postoperative height of the affected vertebral body was significantly improved (P < 0.05). The restoration of vertebral body height in group B was more evident than that in group A (P < 0.05). The preoperative VAS and ODI scores in group B were significantly higher than those in group A (P < 0.05). After surgical treatment, pain relief and daily activity function in both groups were significantly improved (P < 0.05), and no significant difference in postoperative scores was detected between the two groups (P > 0.05).
Conclusion:
Intravertebral cleft exhibits specific clinical and imaging as well as bone cement formation characteristics. PKP can effectively restore the affected vertebral body height, alleviate pain, and improve daily activity function of patients.
doi:10.4103/0019-5413.125498
PMCID: PMC3931154  PMID: 24600064
Intravertebral cleft; osteoporosis vertebral compression fracture; percutaneous kyphoplasty
17.  Comparison of the Results of Balloon Kyphoplasty Performed at Different Times after Injury 
Objective
Balloon kyphoplasty is a minimally invasive procedure that is mainly performed for refractory pain due to osteoporotic compression fractures. The purpose of this study was to evaluate the results of balloon kyphoplasty performed at different times after an injury.
Methods
In this retrospective study, the records of 99 patients who underwent one level of balloon kyphoplasty between January 2005 and December 2007 were reviewed. The patients were divided into three groups : 21 patients treated within 3 weeks of an injury (the acute group), 49 treated within 3 weeks to 2 months of an injury (the subacute group), and 29 patients treated at more than 2 months after an injury (the chronic group). Clinical outcomes were assessed using a visual analogue scale (VAS). In addition, modified MacNab's grading criteria was used to assess the subjective patient outcome. The radiology findings, including vertebral height restoration and procedure related complications, were analyzed based on the different time intervals after the injury.
Results
Patients in all three groups achieved marked pain relief in terms of the VAS within 7 days of the procedure. Good or excellent results were achieved by most patients in all three groups. However, the height restoration, the main advantage to performing a balloon kyphoplasty, was not achieved in the chronic group. Moreover, evidence of complications including cement leakage was observed significantly less frequently in the subacute group compared to the other two groups.
Conclusion
Although balloon kyphoplasty is an effective treatment for osteoporotic compression fractures, with regard to pain relief, the subacute stage appears to be optimal for treating patients with a balloon kyphoplasty in terms of achieving the best outcomes with minimal complications.
doi:10.3340/jkns.2010.47.3.199
PMCID: PMC2851090  PMID: 20379472
Balloon kyphoplasty; Osteoporosis; Compression fracture
18.  Complications and safety aspects of kyphoplasty for osteoporotic vertebral fractures: a prospective follow-up study in 102 consecutive patients 
Background
Kyphoplasty represents an established minimal-invasive method for correction and augmentation of osteoporotic vertebral fractures. Reliable data on perioperative and postoperative complications are lacking in the literature. The present study was designed to evaluate the incidence and patterns of perioperative complications in order to determine the safety of this procedure for patients undergoing kyphoplasty.
Patients and Methods
We prospectively enrolled 102 consecutive patients (82 women and 20 men; mean age 69) with 135 operatively treated fractured vertebrae who underwent a kyphoplasty between January 2004 to June 2006. Clinical and radiological follow-up was performed for up 6 months after surgery.
Results
Preoperative pain levels, as determined by the visual analogous scale (VAS) were 7.5 +/- 1.3. Postoperative pain levels were significantly reduced at day 1 after surgery (VAS 2.3 +/- 2.2) and at 6-month follow-up (VAS 1.4 +/- 0.9). Fresh vertebral fractures at adjacent levels were detected radiographically in 8 patients within 6 months. Two patients had a loss of reduction with subsequent sintering of the operated vertebrae and secondary spinal stenosis. Accidental cement extravasation was detected in 7 patients in the intraoperative radiographs. One patient developed a postoperative infected spondylitis at the operated level, which was treated by anterior corporectomy and 360 degrees fusion. Another patient developed a superficial wound infection which required surgical revision. Postoperative bleeding resulting in a subcutaneous haematoma evacuation was seen in one patient.
Conclusion
The data from the present study imply that percutaneous kyphoplasty can be associated with severe intra- and postoperative complications. This minimal-invasive surgical procedure should therefore be performed exclusively by spine surgeons who have the capability of managing perioperative complications.
doi:10.1186/1754-9493-2-2
PMCID: PMC2248169  PMID: 18271950
19.  Kyphoplasty in osteoporotic vertebral compression fractures - Guidelines and technical considerations 
Osteoporotic vertebral compression fractures are a menace to the elderly generation causing diminished quality of life due to pain and deformity. At first, conservative treatment still is the method of choice. In case of resulting deformity, sintering and persistent pain vertebral cement augmentation techniques today are widely used. Open correction of resulting deformity by different types of osteotomies addresses sagittal balance, but has comparably high morbidity.
Besides conventional vertebral cement augmentation techniques balloon kyphoplasty has become a popular tool to address painful thoracic and lumbar compression fractures. It showed improved pain reduction and lower complication rates compared to standard vertebroplasty. Interestingly the results of two placebo-controlled vertebroplasty studies question the value of cement augmentation, if compared to a sham operation. Even though there exists now favourable data for kyphoplasty from one randomised controlled trial, the absence of a sham group leaves the placebo effect unaddressed. Technically kyphoplasty can be performed with a transpedicular or extrapedicular access. Polymethyl methacrylate (PMMA)-cement should be favoured, since calcium phosphate cement showed inferior biomechanical properties and less effect on pain reduction especially in less stable burst fractures. Common complications of kyphoplasty are cement leakage and adjacent segment fractures. Rare complications are toxic PMMA-monomer reactions, cement embolisation, and infection.
doi:10.1186/1749-799X-6-43
PMCID: PMC3170323  PMID: 21854577
Kyphoplasty; vertebroplasty; osteoporosis; spinal fractures
20.  Efficacy of Unipedicular Baloon Kyphoplasty for Treatment of Multiple Myeloma Vertebral Lesions 
Asian Spine Journal  2011;5(3):162-168.
Study Design
A retrospective cohort study.
Purpose
To analyze differences in between the unipedicular vs. bipedicular balloon kyphoplasty for the treatment of multiple myeloma lesions.
Overview of Literature
Both vertebroplasty and kyphoplasty are reported to be effective for the treatment of vertebral compression fractures in multiple myeloma patients. Kyphoplasty is often performed with a bipedicular approach while vertebroplasty with a monopedicular approach. Monopedicular kyphoplasty is investigated as a viable surgical technique alternatively in comparison with the bipedicular method.
Methods
We performed 37 vertebral body augmentation procedures, 18 vertebroplasty (group A) and 19 kyphoplasty, 9 unipedicular approaches (group B1) and 10 bipedicular approaches (group B2), on 14 patients affected by multiple myeloma with a mean clinical and radiographic follow up of more than 12 months.
Results
Both kyphoplasty techniques lead to a better postoperative improvement of the vertebral height and kyphotic deformity if compared with the vertebroplasty, with a statistical significance for the body height restoration only (p = 0.0066). The unipedicular and the bipedicular kyphoplasty have similar results in term of kyphotic deformity correction and height restoration. The 85.7% (12/14) of the patients had an immediate improvement of the pain and no difference between the vertebroplasty and kyphoplasty groups were observed regarding the pain. We observed a 24.3% of cement leakage in all groups with no clinical symptoms and noticed that the risk of extravasations was higher in multilevel treatment, in bipedicular kyphoplasty procedures and in patients not treated previously with a bone marrow transplant.
Conclusions
Both vertebroplasty and kyphoplasty are effective in treating vertebral compression fracture due to multiple myeloma. Unipedicular kyphoplasty could give equivalent results as with bipedicular kyphoplasty in multilevel disease, aiming only to restore the sagittal alignment of the spine and the height of the vertebral body especially at the thoracolumbar spinal segment.
doi:10.4184/asj.2011.5.3.162
PMCID: PMC3159064  PMID: 21892388
Unipedicular; Kyphoplasty; Vertebroplasty; Multiple myeloma
21.  Kyphoplasty for the treatment of incomplete osteoporotic burst fractures 
European Spine Journal  2010;19(6):893-900.
Kyphoplasty has become a standard procedure in the treatment of painful osteoporotic compression fractures. According to current guidelines, involvement of the posterior wall of the vertebral body is a relative contraindication. From February 2002 until January 2008, 97 patients with at least one AO classification A 3.1 fracture were treated by kyphoplasty. There was a structured follow-up for the medium-term evaluation of the patients’ outcome. Ninety-seven patients (68 of whom were females and 29 of whom were males) with involvement of the vertebra’s posterior margin averaging 76.1 ± 12.36 (59–98) years were treated by kyphoplasty. The fractures of 75 patients were caused by falls from little height, 5 patients had suffered traffic accidents and in the case of 17 patients, no type of trauma was remembered. According to the AO classification, there were 109 A 3.1.1 and one A3.1.3 injuries. Prior to surgery, all patients were neurologically without pathological findings. Seventy-nine fractures were accompanied by a narrowing of the spinal canal [average of 15% (10–40)]. Overall, 134 vertebras were treated by Balloon kyphoplasty (81 × 1 segment, 22 × 2 segments, 3 × 3 segments). In 47.4% of the patients, cement leakage was observed after surgery. All patients with cement extravasation, however, were clinically unremarkable. Using the visual analog scale, patients stated that prior to surgery their pain averaged 8.1, whereas after surgery it significantly decreased and averaged 1.6 (p < 0.001). In geriatric patients with osteoporotic vertebral fractures with partial inclusion of the posterior wall of the vertebral body, kyphoplasty is an effective procedure with few complications.
doi:10.1007/s00586-010-1281-5
PMCID: PMC2899985  PMID: 20135334
Kyphoplasty; Burst fracture; Posterior wall; Vertebroplasty; Vertebral compression fractures
22.  Safety and efficacy of vertebroplasty: Early results of a prospective one-year case series of osteoporosis patients in an academic high-volume center 
Indian Journal of Orthopaedics  2009;43(3):228-233.
Background:
Vertebroplasty (VP) is a cost-efficient alternative to kyphoplasty. However, it is considered inferior when it comes to maintaining safety and in vertebral body (VB) height restoration. We assess the safety and efficacy of VP in alleviating pain, improving quality of life (QoL), and restoring alignment.
Materials and Methods:
In a prospective monocenter case series, from April 2007 until July 2008, 1,422 vertebroplasties were performed, during 307 interventions, in 279 patients with traumatic, lytic, and osteoporotic fractures with 28 repeat interventions, for new fractures after the primary surgery, in 28 patients. The 226 interventions (n=203 patients) done for osteoporotic fractures were analyzed for demographics, treatment and radiographic details, pain alleviation, QoL improvement [NASS and Euroqol (EQ-5D)] and complications.
Results:
Osteoporotic patient sample consisted of 77.8% (n=158) females with a median age of 78 years and 45 males who had the same median age. Around 69% of these patients were ASA (American Society of Anesthesiologists) grade 3 and above. On an average there were 1.8 VBs fractured and five VBs treated,whereas the most frequently performed cementations were in six (35.6%, n=80) or five (19.6%, n=44) levels. About 36.5%, (n=414) of the interventions were localized at the thoraco–lumbar junction (Th12–L2). On applying the Genant classification, there was a slight height reduction in 13.1% (n=29), a medium loss in 34.3% (n=78), and a severe loss of height in 52.6% (n=119). The pre-operative pain was assessed by the visual analog scale (VAS) and decreased from 56.7 to 41.4 pts after two months. Accordingly, the QoL on the EQ-5D measure (0.6 to 1) improved from 0.32 pts before surgery to 0.58 pts after two months. The pre-operative Beck index (anterior height/posterior height) improved from a mean of 0.66 preoperative to 0.80 post-operative and remained stable at two months post-operatively. There were cement leakages in 33% of the fractured VBs and in 0.8% of the prophylactically cemented VBs; there were symptoms in 7.1%, and most of them were temporary hypotension and one pulmonary cement embolism that remained asymptomatic.
Conclusion:
If routinely used, VP is a safe and efficient treatment option for osteoporotic vertebral fractures with regard to pain relief and improvement of the QoL. Even segmental re-alignment can be achieved to a certain extent with proper patient positioning.
doi:10.4103/0019-5413.53452
PMCID: PMC2762175  PMID: 19838343
Osteoporosis; percutaneous vertebroplasty; vertebral fractures
23.  Comparison of 5766 Vertebral Compression Fractures Treated With or Without Kyphoplasty 
Background
The majority of the 700,000 osteoporotic vertebral compression fractures (VCFs) that occur annually in the United States affect women. The total treatment costs exceed $17 billion and approximate the total costs of breast cancer ($13 billion) and heart disease ($19 billion). Balloon-assisted percutaneous vertebral augmentation with bone cement (kyphoplasty) reportedly reduces VCF-related pain and accelerates return of independent functional mobility. Kyphoplasty may decrease overall cost of VCF treatment costs by reducing use of posttreatment medical resources.
Questions/purposes
We evaluated complications, mortality, posthospital disposition, and treatment costs of kyphoplasty compared with nonoperative treatment using the Nationwide Inpatient Sample database.
Methods
We identified 5766 VCFs (71% female) in patients 65 years of age or older with nonneoplastic VCF as the primary diagnosis in nonroutine hospital admissions; 15.3% underwent kyphoplasty. Demographic data, medical comorbidities, and fracture treatment type were recorded. Outcomes, including complications, mortality, posthospital disposition, and treatment costs, were compared for each treatment type.
Results
Women were more likely to be treated with kyphoplasty than were men. Patients undergoing kyphoplasty had comorbidity indices equivalent to those treated nonoperatively. Kyphoplasty was associated with a greater likelihood of routine discharge to home (38.4% versus 21.0% for nonoperative treatment), a lower rate of discharge to skilled nursing (26.1% versus 34.8%) or other facilities (35.7% versus 47.1%), a complication rate equivalent to nonoperative treatment (1.7% versus 1.0%), and a lower rate of in-hospital mortality (0.3% versus 1.6%). Kyphoplasty was associated with higher cost of hospitalization (mean $37,231 versus $20,112).
Conclusions
Kyphoplasty for treatment of VCF in well-selected patients may accelerate the return of independent patient function as indicated by improved measures of hospital discharge. The initially higher cost of treatment may be offset by the reduced use of posthospital medical resources.
Level of Evidence
Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-010-1279-7
PMCID: PMC2882011  PMID: 20177836
24.  Revision strategies for complications and failure of vertebroplasties 
European Spine Journal  2008;17(7):982-988.
Percutaneous vertebroplasty is widely discussed in the management of osteoporotic spinal compression fracture, but few reports are available concerning salvage procedures after failure of this technique. We studied 22 percutaneous vertebroplasty patients who required revision surgery upon presentation of new symptoms postoperatively. The indications for revision surgery included recurrent intractable back pain with no response to medical treatment, infectious spondylitis, cement leakage with neurologic deficit, and cement dislodgement and/or fragmentation. Five patients underwent repeated percutaneous vertebroplasty of the initially cemented vertebrae. Seventeen patients underwent anterior, posterior, or combined anterior and posterior surgery. Four patients required a third surgical procedure because of poor augmentation with cement, subsidence of the anterior bone graft, or pullout of the instrumentation. Finally, four (18%) patients underwent repeat vertebroplasty, two (9%) patients underwent anterior surgery only, one (5%) patient underwent posterior surgery only, and 15 (68%) patients underwent combined anterior and posterior surgery; all but one regained ambulatory status equivalent to that prior to surgery. In conclusion, percutaneous vertebroplasty is a simple and effective, but not risk- or complication-free procedure for the treatment of osteoporotic spinal compression fracture. The spine surgeon should be familiar with varied approaches and techniques for revision surgery. Combined anterior and posterior surgery seems to be the most secure salvage method to treat severely osteoporotic patients in whom percutaneous vertebroplasty initially failed.
doi:10.1007/s00586-008-0680-3
PMCID: PMC2443258  PMID: 18446385
Revision surgery; Percutaneous vertebroplasty; Osteoporotic spinal compression fracture; Bone cement
25.  Balloon Kyphoplasty through Extrapedicular Approach in the Treatment of Middle Thoracic Osteoporotic Compression Fracture : T5-T8 Level 
Objective
Kyphoplasty performed in the middle thoracic spine presents technical challenges that differ from those in the lower thoracic or lumbar region due to small pedicle size and angular severity for thoracic kyphosis. The purpose of this study was to evaluate the efficacy of balloon kyphoplasty through extrapedicular approach for the treatment of intractable osteoporotic compression fractures in the middle thoracic spine.
Methods
The patients who were performed with one level balloon kyphoplasty through extrapedicular approach due to painful osteoporotic compression fractures at T5-T8 from June 2003 to July 2005 were retrospectively analyzed. Imaging and clinical features were analyzed including involved vertebrae level, vertebral height, injected cement volume, clinical outcome and complications.
Results
Eighteen female patients (age ranged from 60 to 77 years old) were included in this study. The average amount of the implanted cement was 4.2±1.5 cc. The mean cobb angle and compression rate were improved from 12.1±6.5° to 8.5±7.2° and from 30% to 15%, respectively. The mean pain score (visual analogue scale) prior to kyphoplasty was 7.9 and it decreased to 3.0 after the procedure. Cement leakage to the adjacent disc (2 cases) and paravertebral soft tissues (1 case) were seen but there were no major complications such as pneumothorax, segmental artery injury, pulmonary embolism, or epidural leakage.
Conclusion
Balloon kyphoplasty through extrapedicular approach is considered as a safe and effective in treating the middle thoracic regions with low complication rate.
doi:10.3340/jkns.2007.42.5.363
PMCID: PMC2588193  PMID: 19096570
Balloon kyphoplasty; Extrapedicular approach; Middle thoracic region; Osteoporotic compression fracture

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