Authors' objectives: To conduct a rapid review to evaluate the clinical effectiveness, safety and cost-effectiveness of percutaneous vertebroplasty or balloon kyphoplasty versus conservative treatment or against each other in the management of vertebral compression fractures (VCF).

Authors' results and conclusions: Most evidence is available for VCF related to osteoporosis. However, most trials are non-blinded with only two small blinded RCTs, leading to low quality evidence overall. Some of the clinical outcomes (pain, quality of life, functionality, mobility and radiographic parameters) are in favour of vertebroplasty or kyphoplasty, with larger effects on the short term in the non-blinded studies. However, most of these outcomes are not statistically significantly different in the two blinded studies. On the long term most of these outcomes improve in both arms of the studies. In the two studies that directly compare both techniques no statistically significant difference is found for most outcomes. For VCF unrelated to osteoporosis only very low quality evidence from one RCT is available. Incidence of complications is rare, but when occurring consequences can be serious and even life-threatening. A lower long-term mortality rate associated with these techniques has been reported but is very uncertain. The results of the economic evaluations are divergent. There is considerable uncertainty and no convincing evidence regarding the clinical effectiveness of either technique compared to conservative treatment. Due to this clinical uncertainty, cost-effectiveness evaluations are highly dependent upon uncertain assumptions.

Authors' recommendations: THE FOLLOWING RECOMMENDATIONS CONCERN EXCLUSIVELY THE PERCUTANEOUS VERTEBROPLASTY AND THE CLASSIC PERCUTANEOUS BALLOON KYPHOPLASTY, EXCLUDING ALL OTHER AND NEWER VERTEBRAL AUGMENTATION TECHNIQUES To the Technical Medical Council and the Commission for the Reimbursement of Inplants and Invasive Medical Devices * Given the limited evidence and the existing uncertainties on the clinical effectiveness and cost-effectiveness of percutaneous vertebroplasty and balloon kyphoplasty, we recommend to apply the same reimbursement tariff for both procedures, but under different nomenclature codes. * We recommend to assess and revise, where necessary, both the limitative list of clinical indications and the required diagnostic modalities in collaboration with the clinical experts in the domain. To the hospital responsible and physicians * In accordance with the law of 2002 relative to the patients’ rights, the patient should be clearly informed of the respective advantages and disadvantages as well as the cost of each alternatives. Recommendations for further clinical research * Future RCTs studying these interventions should include an arm with optimal pain management combined with a sham intervention and a blinded assessment of outcomes. * More research is needed to explore the optimal selection of patients that might benefit most from vertebral augmentation interventions.

Authors' methods: Systematic literature review of randomised controlled trials (RCTs), systematic reviews of RCTs, and full economic evaluations in Medline, Embase, Cochrane and CRD (CDSR, DARE, HTA, NHS EED and CENTRAL). Analysis of national administrative databases and industry-launched survey results.

Project Status: Completed

Year Published: 2015

URL for published report: https://doi.org/10.57598/R255C

URL for additional information: https://kce.fgov.be/en/publications/all-reports/percutaneous-vertebroplasty-and-balloon-kyphoplasty

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Belgium

DOI: 10.57598/R255C

Organisation Name: Belgian Health Care Knowledge Centre

Contact Address: Administrative Centre Botanique, Doorbuilding (10th floor), Boulevard du Jardin Botanique 55, B-1000 Brussels, Belgium tel: +32 2 287 33 88 fax: +32 2 287 33 85

Contact Name: info@kce.fgov.be

Contact Email: info@kce.fgov.be

Copyright: Belgian Health Care Knowledge Centre (KCE)