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European Spine Journal : Official... Aug 2007This systematic review updates the understanding of the evidence base for balloon kyphoplasty (BKP) in the management of vertebral compression fractures. Detailed... (Meta-Analysis)
Meta-Analysis Review
This systematic review updates the understanding of the evidence base for balloon kyphoplasty (BKP) in the management of vertebral compression fractures. Detailed searches of a number of electronic databases were performed from March to April 2006. Citation searches of included studies were undertaken and no language restrictions were applied. All controlled and uncontrolled studies were included with the exception of case reports. Prognostic factors responsible for pain relief and cement leakage were examined using meta-regression. Combined with previous evidence, a total of eight comparative studies (three against conventional medical therapy and five against vertebroplasty) and 35 case series were identified. The majority of studies were undertaken in older women with osteoporotic vertebral compression fractures with long-term pain that was refractory to medical treatment. In direct comparison to conventional medical management, patients undergoing BKP experienced superior improvements in pain, functionality, vertebral height and kyphotic angle at least up to 3-years postprocedure. Reductions in pain with BKP appeared to be greatest in patients with newer fractures. Uncontrolled studies suggest gains in health-related quality of life at 6 and 12-months following BKP. Although associated with a finite level of cement leakage, serious adverse events appear to be rare. Osteoporotic vertebral compression fractures appear to be associated with a higher level of cement leakage following BKP than non-osteoporotic vertebral compression fractures. In conclusion, there are now prospective studies of low bias, with follow-up of 12 months or more, which demonstrate balloon kyphoplasty to be more effective than medical management of osteoporotic vertebral compression fractures and as least as effective as vertebroplasty. Results from ongoing RCTs will provide further information in the near future.
Topics: Adult; Aged; Aged, 80 and over; Female; Fractures, Compression; Humans; Male; Middle Aged; Osteoporosis; Spine; Treatment Outcome; Vertebroplasty
PubMed: 17277923
DOI: 10.1007/s00586-007-0308-z -
Spine Aug 2006Systematic literature review. (Review)
Review
STUDY DESIGN
Systematic literature review.
OBJECTIVE
To evaluate the safety and efficacy of vertebroplasty and kyphoplasty using the data presented in published clinical studies, with respect to patient pain relief, restoration of mobility and vertebral body height, complication rate, and incidence of new adjacent vertebral fractures.
SUMMARY OF BACKGROUND DATA
Vertebroplasty and kyphoplasty have been gaining popularity for treating vertebral fractures. Current reviews provide an overview of the procedures but are not comprehensive and tend to rely heavily on personal experience. This article aimed to compile all available data and evaluate the clinical outcome of the 2 procedures.
METHODS
This is a systematic review of all the available data presented in peer-reviewed published clinical trials. The methodological quality of included studies was evaluated, and data were collected targeting specific standard measurements. Where possible, a quantitative aggregation of the data was performed.
RESULTS
A large proportion of subjects had some pain relief, including 87% with vertebroplasty and 92% with kyphoplasty. Vertebral height restoration was possible using kyphoplasty (average 6.6 degrees ) and for a subset of patients using vertebroplasty (average 6.6 degrees ). Cement leaks occurred for 41% and 9% of treated vertebrae for vertebroplasty and kyphoplasty, respectively. New fractures of adjacent vertebrae occurred for both procedures at rates that are higher than the general osteoporotic population but approximately equivalent to the general osteoporotic population that had a previous vertebral fracture.
CONCLUSIONS
The problem with stating definitely that vertebroplasty and kyphoplasty are safe and effective procedures is the lack of comparative, blinded, randomized clinical trials. Standardized evaluative methods should be adopted.
Topics: Humans; Incidence; Kyphosis; Orthopedic Procedures; Palliative Care; Spinal Fractures; Spine; Treatment Outcome
PubMed: 16924218
DOI: 10.1097/01.brs.0000229254.89952.6b -
European Spine Journal : Official... Jul 2006The aim of this study is to evaluate the efficacy and safety of balloon kyphoplasty (BK) in the management of vertebral compression fractures (VCFs). This study is based... (Meta-Analysis)
Meta-Analysis Review
The aim of this study is to evaluate the efficacy and safety of balloon kyphoplasty (BK) in the management of vertebral compression fractures (VCFs). This study is based on a systematic review of the literature (until October 2004) and meta-analysis of clinical studies assessing the efficacy and safety of BK in the treatment of VCFs. Estimates of effect were based on a random effects model. Meta-regression analyses were carried out where required. A total of 26 studies met the inclusion criteria. Although studies displayed considerable methodological limitations, the results of the clinical series indicate significant improvements in pain intensity, vertebral height, sagittal alignment, functional capacity, and quality of life. Compared with conventional medical management, BK afforded significant improvement in pain intensity and mobility. Likewise, a significant reduction was observed in vertebral collapse, kyphotic deformity, the development of new vertebral fractures, and hospital stay. Compared with vertebroplasty, the technique reduced the loss of height and the degree of kyphotic deformity, and afforded a significantly lower leakage rate-with no differences in relation to other variables. Regarding adverse effects, leakage affected 7% of all levels treated, while complications were recorded in 2% of the patients, and new vertebral fractures in 16%. The available evidence suggests that BK can be effective and safe in application to VCFs. However, existing studies evince substantial methodological limitations and relatively short follow-up periods. Better clinical research is required to determine the capacity of BK to avoid the functional and physiological sequelae of VCFs and to define the true role of the technique among the existing therapeutic options.
Topics: Catheterization; Female; Follow-Up Studies; Fractures, Compression; Humans; Male; Minimally Invasive Surgical Procedures; Retrospective Studies; Spinal Fractures; Time Factors; Treatment Outcome
PubMed: 16429288
DOI: 10.1007/s00586-005-0048-x