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Evidence-based Spine-care Journal Nov 2011Comparative effectiveness review.
STUDY DESIGN
Comparative effectiveness review.
STUDY RATIONALE
The spine is among the most common location for bony metastases. In many cases these metastases cause fractures leading to increased morbidity. Percutaneous cement augmentation techniques have been developed over the past decades for the treatment of these fractures; however, there are little data comparing these interventions.
CLINICAL QUESTION
Do comparative studies of vertebral cement augmentation for fractures caused by spinal tumors provide evidence of improved patient outcomes?
METHODS
A systematic search and review of the literature was undertaken to identify studies published through June 8, 2011. Two individuals independently reviewed articles based on inclusion and exclusion criteria which were set a priori. Each article was evaluated using a predefined quality-rating system and an overall strength of evidence determined.
RESULTS
The literature consists primarily of case series. Only two studies comparing vertebroplasty with kyphoplasty were found. Pain scores in both treatment groups were significantly decreased relative to preoperative scores and appear to have been sustained at follow-up times to 1 year. It is unclear whether one treatment provided superior pain relief than the other. Both studies reported decreased analgesic use after both treatments but neither study compared use between treatment groups. Balloon rupture occurred in one kyphoplasty patient in one study and extravasation of polymethylmethacrylate (PMMA) cement into the anterior perivertebral soft tissue was seen in another patient in the vertebroplasty group and no patients in the kyphoplasty group in the other study. No other intraoperative or postoperative complications occurred.
CONCLUSIONS
There is only limited evidence from comparative studies (two small retrospective cohort studies) regarding the benefits of vertebroplasty versus kyphoplasty in patients with spinal fractures caused by tumors. Both appear to be effective in reducing pain with relatively few complications. Whether one method provides superior results over the other cannot be determined from the available evidence. Study limitations preclude making definitive conclusions. The overall strength of evidenced is very low.
PubMed: 23230404
DOI: 10.1055/s-0031-1274755 -
Orthopaedic Surgery Aug 2012Therapeutic vertebral cement augmentation for the treatment of painful skeletal diseases, although widely applied for more than several decades, still has not thoroughly... (Review)
Review
Therapeutic vertebral cement augmentation for the treatment of painful skeletal diseases, although widely applied for more than several decades, still has not thoroughly resolve the problem of cement extravasation. Based on a review of literature published, the present study was to provide a systematic review of the current understanding of pulmonary cement embolism (PCE) associated with percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP), and to summarize the incidence, clinical features, prophylaxis and therapeutic management of PCE after vertebral cement reinforcement. The reported incidence of PCE ranges widely, from 2.1% to 26%. Asymptomatic PCE is a common condition without permanent clinical sequelae. Nevertheless, it is emergent once a symptomatic PCE is presented. Close attention and effective pre-measures should be taken to avoid this catastrophic complication.
Topics: Bone Cements; Fractures, Compression; Humans; Kyphoplasty; Postoperative Complications; Pulmonary Embolism; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 22927153
DOI: 10.1111/j.1757-7861.2012.00193.x -
European Spine Journal : Official... Sep 2012To assess the safety and efficacy of balloon kyphoplasty (KP) compared with percutaneous vertebroplasty (VP) and provide recommendations for using these procedures to... (Meta-Analysis)
Meta-Analysis Review
Balloon kyphoplasty versus percutaneous vertebroplasty in treating osteoporotic vertebral compression fracture: grading the evidence through a systematic review and meta-analysis.
OBJECTIVE
To assess the safety and efficacy of balloon kyphoplasty (KP) compared with percutaneous vertebroplasty (VP) and provide recommendations for using these procedures to treat osteoporotic vertebral compression fractures (OVCF).
METHODS
A systematic search of all studies published through March 2012 was conducted using the MEDLINE, EMBASE, OVID, ScienceDirect and Cochrane CENTRAL databases. The randomized controlled trials (RCTs) and non-randomized controlled trials that compared KP to VP and provided data on safety and clinical effects were identified. Demographic characteristics, adverse events and clinical outcomes were manually extracted from all of the selected studies. The evidence quality levels and recommendations were assessed using the GRADE system.
RESULTS
Twelve studies encompassing 1,081 patients met the inclusion criteria. Subgroup meta-analyses were performed according to the study design. In the RCT subgroup, there were significant differences between the two procedures in short-term visual analog scale (VAS), long-term kyphosis angles, operative times and anterior vertebrae heights. In the cohort study subgroup, there were significant differences between the two procedures in short- and long-term VAS, short- and long-term Oswestry Disability Index (ODI), cement leakage rates, short- and long-term kyphosis angles, operative times and anterior vertebrae heights. However, there were no significant differences in long-term VAS or adjacent vertebral fracture rates in the RCT subgroup. There were no significant differences in short- or long-term VAS, short- or long-term ODI, cement leakage rates, adjacent vertebral fracture rates, short- or long-term kyphosis angles or anterior vertebrae heights in the CCT subgroup, and the adjacent vertebral fracture rates did not differ significantly in the cohort study subgroup. The overall GRADE system evidence quality was very low, which lowers our confidence in their recommendations.
CONCLUSIONS
KP and VP are both safe and effective surgical procedures for treating OVCF. KP may be superior to VP in patients with large kyphosis angles, vertebral fissures, fractures in the posterior edge of the vertebral body or significant height loss in the fractured vertebrae. Due to the poor quality of the evidence currently available, high-quality RCTs are required.
Topics: Fractures, Compression; Humans; Kyphoplasty; Minimally Invasive Surgical Procedures; Osteoporotic Fractures; Pain; Recovery of Function; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 22832872
DOI: 10.1007/s00586-012-2441-6 -
Pain Physician 2012Vertebroplasty and kyphoplasty have recently been used to treat painful osteoporotic compression fractures. Early clinical results have been encouraging, but very little... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Vertebroplasty and kyphoplasty have recently been used to treat painful osteoporotic compression fractures. Early clinical results have been encouraging, but very little is known about the consequences of augmentation with cement for adjacent, unaugmented levels.
OBJECTIVE
This study performed a systemic review of the studies concerning whether the incidence of subsequent vertebral body fracture after vertebral augmentation therapy would be increased long-term.
STUDY DESIGN
A meta-analysis of randomized controlled trials was performed comparing the long-term incidence of subsequent vertebral body fracture between vertebral augmentation surgeries like vertebroplasty and kyphoplasty and conventional nonsurgical management.
SETTING
The MEDLINE, EMBASE, ISI Web of Science and Cochrane Library databases and abstracts published in annual proceedings were systematically searched for evidence.
METHODS
Relevant reports were reviewed by 2 reviewers independently and the references from these reports were searched for additional trials, using guidelines set by QUOROM statement criteria.
RESULTS
Pooled results from 2 randomized controlled trials showed no significant increase of the secondary fracture rate after vertebral augmentation therapy compared with that of conventional treatment (P = 0.07). Few large-sample randomized controlled trials were specifically performed to investigate new fractures as an outcome of vertebroplasty or kyphoplasty.
LIMITATIONS
There were few data sources from which to extract abstracted data or published studies. There were only 2 randomized controlled trials that met criteria.
CONCLUSIONS
Although vertebral augmentation therapies, such as vertebroplasty and kyphoplasty, have been widely used in clinics to treat patients' back pain caused by vertebral compression fractures due to osteoporosis, no evidence shows that they can increase the fracture of adjacent vertebral bodies.
Topics: Bone Cements; Fractures, Compression; Humans; Incidence; Postoperative Complications; Randomized Controlled Trials as Topic; Spinal Fractures; Spine; Vertebroplasty
PubMed: 22828697
DOI: No ID Found -
European Spine Journal : Official... Sep 2012To determine if differences in safety or efficacy exist between balloon kyphoplasty (BKP), vertebroplasty (VP) and non-surgical management (NSM) for the treatment of... (Comparative Study)
Comparative Study Review
PURPOSE
To determine if differences in safety or efficacy exist between balloon kyphoplasty (BKP), vertebroplasty (VP) and non-surgical management (NSM) for the treatment of osteoporotic vertebral compression fractures (VCFs).
METHODS
As of February 1, 2011, a PubMed search (key words: kyphoplasty, vertebroplasty) resulted in 1,587 articles out of which 27 met basic selection criteria (prospective multiple-arm studies with cohorts of ≥ 20 patients). This systematic review adheres to preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines.
RESULTS
Pain reduction in both BKP (-5.07/10 points, P < 0.01) and VP (-4.55/10, P < 0.01) was superior to that for NSM (-2.17/10), while no difference was found between BKP/VP (P = 0.35). Subsequent fractures occurred more frequently in the NSM group (22 %) compared with VP (11 %, P = 0.04) and BKP (11 %, P = 0.01). BKP resulted in greater kyphosis reduction than VP (4.8º vs. 1.7°, P < 0.01). Quality of life (QOL) improvement showed superiority of BKP over VP (P = 0.04), along with a trend for disability improvement (P = 0.08). Cement extravasation was less frequent in the BKP (P = 0.01). Surgical intervention within the first 7 weeks yielded greater pain reduction than VCFs treated later.
CONCLUSIONS
BKP/VP provided greater pain relief and fewer subsequent fractures than NSM in osteoporotic VCFs. BKP is marginally favored over VP in disability improvement, and significantly favored in QOL improvement. BKP had a lower risk of cement extravasation and resulted in greater kyphosis correction. Despite this analysis being restricted to Level I and II studies, significant heterogeneity suggests that the current literature is delivering inconsistent messages and further trials are needed to delineate confounding variables.
Topics: Controlled Clinical Trials as Topic; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Pain; Spinal Fractures; Vertebroplasty
PubMed: 22543412
DOI: 10.1007/s00586-012-2314-z -
International Orthopaedics Sep 2011There is still debate over whether vertebroplasty (VP) or kyphoplasty (KP) is superior for the treatment of osteoporosis vertebral compression fractures (VCFs). We... (Comparative Study)
Comparative Study Meta-Analysis
Percutaneous vertebroplasty versus balloon kyphoplasty for treatment of osteoporotic vertebral compression fracture: a meta-analysis of randomised and non-randomised controlled trials.
PURPOSE
There is still debate over whether vertebroplasty (VP) or kyphoplasty (KP) is superior for the treatment of osteoporosis vertebral compression fractures (VCFs). We performed a systematic review and meta-analysis of randomised and non-randomised controlled trials comparing VP with KP to reach a relatively conclusive answer.
METHODS
We searched computerised databases comparing efficacy and safety of VP and KP in osteoporotic fractures. These trials reported pain relief (Visual Analogue Scale), disability (Oswestry disability score) and complications (i.e., cement leakage, incident fractures) as the primary outcome.
RESULTS
Eight studies involving 848 patients were identified. The outcome showed that VP is more effective in the short-term (no more than seven days) pain relief. Kyphoplasty had a superior capability for intermediate-term (around three months) functional improvement. As for long-term pain relief and functional improvement, there is no significant difference between these two interventions. Consistently, both interventions have similar risk for subsequent fracture and cement leakage.
CONCLUSION
Thus considering the higher cost of the KP procedure, we recommend VP over KP for the treatment of osteoporotic VCFs.
Topics: Aged; Bone Cements; Cementation; Databases, Bibliographic; Disability Evaluation; Female; Fractures, Compression; Humans; Kyphoplasty; Male; Osteoporotic Fractures; Pain; Pain Measurement; Prosthesis Failure; Randomized Controlled Trials as Topic; Spinal Fractures
PubMed: 21637959
DOI: 10.1007/s00264-011-1283-x -
Osteoporosis International : a Journal... Nov 2011This consensus article reviews the various aspects of the non-pharmacological management of osteoporosis, including the effects of nutriments, physical exercise,... (Review)
Review
This consensus article reviews the various aspects of the non-pharmacological management of osteoporosis, including the effects of nutriments, physical exercise, lifestyle, fall prevention, and hip protectors. Vertebroplasty is also briefly reviewed. Non-pharmacological management of osteoporosis is a broad concept. It must be viewed as an essential part of the prevention of fractures from childhood through adulthood and the old age. The topic also includes surgical procedures for the treatment of peripheral and vertebral fractures and the post-fracture rehabilitation. The present document is the result of a consensus, based on a systematic review and a critical appraisal of the literature. Diets deficient in calcium, proteins or vitamin D impair skeletal integrity. The effect of other nutriments is less clear, although an excessive consumption of sodium, caffeine, or fibres exerts negative effects on calcium balance. The deleterious effects of tobacco, excessive alcohol consumption and a low BMI are well accepted. Physical activity is of primary importance to reach optimal peak bone mass but, if numerous studies have shown the beneficial effects of various types of exercise on bone mass, fracture data as an endpoint are scanty. Fall prevention strategies are especially efficient in the community setting, but less evidence is available about their effectiveness in preventing fall-related injuries and fractures. The efficacy of hip protectors remains controversial. This is also true for vertebroplasty and kyphoplasty. Several randomized controlled studies had reported a short-term advantage of vertebroplasty over medical treatment for pain relief, but these findings have been questioned by recent sham-controlled randomized clinical studies.
Topics: Accidental Falls; Age Factors; Bone Density; Diet; Dietary Supplements; Exercise; Exercise Therapy; Female; Humans; Kyphoplasty; Life Style; Male; Osteoporosis; Osteoporotic Fractures; Postmenopause; Protective Devices; Risk Factors; Spinal Fractures; Vertebroplasty
PubMed: 21360219
DOI: 10.1007/s00198-011-1545-x -
BMC Palliative Care Sep 2009Spinal fractures are a common source of morbidity in cancer patients. Balloon Kyphoplasty (BKP) is a minimally invasive procedure designed to stabilize fractures and...
BACKGROUND
Spinal fractures are a common source of morbidity in cancer patients. Balloon Kyphoplasty (BKP) is a minimally invasive procedure designed to stabilize fractures and correct vertebral deformities. We performed a meta-analysis to determine the efficacy and safety of BKP for spinal fractures in cancer patients.
METHODS
We searched several electronic databases up to September 2008 and the reference lists of relevant publications for studies reporting on BKP in patients with spinal fractures secondary to osteolytic metastasis and multiple myeloma. Outcomes sought included pain relief, functional capacity, quality of life, vertebral height, kyphotic angle and adverse events. Studies were assessed for methodological bias, and estimates of effect were calculated using a random-effects model. Potential reasons for heterogeneity were explored.
RESULTS
The literature search revealed seven relevant studies published from 2003 to 2008, none of which were randomized trials. Analysis of those studies indicated that BKP resulted in less pain and better functional outcomes, and that these effects were maintained up to 2 years post-procedure. While BKP also improved early vertebral height loss and spinal deformity, these effects were not long-term. No serious procedure-related complications were described. Clinically asymptomatic cement leakage occurred in 6% of all treated levels, and new vertebral fractures in 10% of patients. While there is a lack of studies comparing BKP to other interventions, some data suggested that BKP provided similar pain relief as vertebroplasty and a lower cement leakage rate.
CONCLUSION
It appears that there is level III evidence showing BKP is a well-tolerated, relatively safe and effective technique that provides early pain relief and improved functional outcomes in patients with painful neoplastic spinal fractures. BKP also provided long-term benefits in terms of pain and disability. However, the methodological quality of the original studies prevents definitive conclusions being drawn. Further investigation into the use of BKP for spinal fractures in cancer patients is warranted.
PubMed: 19740423
DOI: 10.1186/1472-684X-8-12 -
European Spine Journal : Official... Sep 2009Balloon kyphoplasty and percutaneous vertebroplasty are relatively recent procedures in the treatment of painful vertebral fractures. There are, however, still some... (Review)
Review
Balloon kyphoplasty and percutaneous vertebroplasty are relatively recent procedures in the treatment of painful vertebral fractures. There are, however, still some uncertainties about the incidence and treatment strategies of pulmonary cement embolisms (PCE). In order to work out a treatment strategy for the management of this complication, we performed a review of the literature. The results show that there is no clear diagnostic or treatment standard for PCE. The literature research revealed that the risk of a pulmonary embolism ranges from 3.5 to 23% for osteoporotic fractures. In cases of asymptomatic patients with peripheral PCE we recommend no treatment besides clinical follow-up; in cases of symptomatic or central embolisms, however, we recommend to proceed according to the guidelines regarding the treatment of thrombotic pulmonary embolisms, which includes initial heparinization and a following 6-month coumarin therapy. In order to avoid any types of embolisms, both procedures should only be performed by experienced surgeons after critical determination of the indications.
Topics: Anticoagulants; Bone Cements; Humans; Osteoporosis; Patient Selection; Postoperative Complications; Pulmonary Embolism; Spinal Curvatures; Spinal Fractures; Vertebroplasty
PubMed: 19575243
DOI: 10.1007/s00586-009-1073-y -
Pain Physician Jul 2007Osteoporosis with subsequent osteoporotic vertebral compression fractures is an increasingly important disease due not only to its significant economic impact but also... (Comparative Study)
Comparative Study Meta-Analysis
BACKGROUND
Osteoporosis with subsequent osteoporotic vertebral compression fractures is an increasingly important disease due not only to its significant economic impact but also to the increasing age of our population. Pain reduction and stabilization are of primary importance with osteoporotic vertebral compression fractures. Although many patients heal with conservative treatment consisting of rest or activity modification, analgesics, and bracing, the management of severe pain compels some patients to seek surgical intervention via 2 procedures: vertebroplasty and kyphoplasty. Although there is abundant support in the literature for both procedures, there remains debate over which procedure can most successfully reduce patients' perception of pain.
OBJECTIVE
To determine the amount of pain reduction using the visual analog scale (VAS) with kyphoplasty and vertebroplasty in the treatment of osteoporotic vertebral compression fractures.
DESIGN
Meta-analysis
METHODS
A systematic review and meta-analysis of the available literature was performed to quantify the amount of pain reduction using the visual analog scale (VAS) between vertebroplasty and kyphoplasty for osteoporotic vertebral compression fractures.
RESULTS
Twenty-one studies, 14 vertebroplasty and 7 kyphoplasty, qualified for inclusion representing totals of 1,046 vertebroplasty and 263 kyphoplasty patients treated, respectively. Kyphoplasty and vertebroplasty resulted in a more than 5 point drop in the VAS in the immediate postoperative period (p<0.00001). Between the two, the difference in early pain relief was not significant. At final follow-up, the long-term VAS was improved for both procedures, but the final follow-up VAS for vertebroplasty and kyphoplasty was not significant when compared to the initial postoperative VAS (p=0.25, p=0.38, respectively).
CONCLUSIONS
The analysis demonstrates that both procedures reduce the amount of pain in the immediate postoperative period by approximately 50%. Both procedures reduce pain in symptomatic osteoporotic vertebral compression fractures that have failed conservative treatment. Randomized controlled trials are needed to provide definitive data on which procedure is the most effective for vertebral compression fractures.
Topics: Fracture Fixation; Fractures, Compression; Fractures, Spontaneous; Humans; Orthopedic Procedures; Osteoporosis; Pain Measurement; Pain, Postoperative; Spinal Fractures
PubMed: 17660858
DOI: No ID Found