Original Title: Application 27.1

Authors' objectives: In 2004–05, an MSAC assessment of vertebroplasty and kyphoplasty for the treatment of vertebral compression fracture was conducted (Medical Services Advisory Committee 2006). On the basis of the evidence presented in that report, the Minister for Health and Ageing accepted recommendations for vertebroplasty to be granted funding on an interim basis, with a planned review of funding within 5 years, and that there was insufficient evidence to support public funding of kyphoplasty at that time. This review updates and expands upon the initial assessment of these procedures. The expanded scope of this review includes a broadening of the restrictions on the type of vertebral fracture eligible for the procedures, and includes an additional indication for kyphoplasty for treatment of painful vertebral fracture. Thus, it was necessary to add new comparators: kyphoplasty as a comparator for vertebroplasty, and conservative management as a comparator for kyphoplasty.

Authors' results and conclusions: Verebroplasty Safety - while cement leakage was found to occur frequently with vertebroplasty (8-72%), clinically important adverse events were rarely associated with the leaks, or with the procedure. The most common adverse events were rib fracture and radicular pain, which usually resolves with medical therapy; both of these appear to occur in approximately 4% of patients undergoing vertebroplasty. Overall, owing to the procedure-specific complications, such as cement leakage, vertebroplasty is not considered to be as safe as conservative management. Comparative effectiveness in osteoporosis-Although there are concerns regarding patient selection and technique in the placebo-controlled trials, they provide good-quality evidence that the addition of vertebroplasty to the conservative management of painful vertebral fractures is no more effective than placebo. Vertebroplasty may have a role in the management of a subgroup of patients with acute, unstable vertebral fractures and intractable pain, but further information is required from good-quality research before any such treatment effect modifications can be confirmed. Kyphoplasty Safety - Cement leakage is commonly associated with kyphoplasty, but adverse clinical consequences are rare. The frequency of cement leakage at any site varied from 7 to 47%. The most common adverse event was radicular pain associated with cement leakage. Overall, owing to the procedure-specific complications, such as cement leakage, kyphoplasty is not considered to be as safe as conservative management. Comparative effectiveness in osteoporosis - Good quality evidence showed that kyphoplasty in addition to conservative management is more effective than conservative management alone in the treatment of vertebral fractures. Kryphoplasty may have a role in the management of vertebral fractures but, in light of the contrasting results between blinded and unblinded studies assessing the similar vertebroplasty procedure, further information is required. Verebroplasty versus Kyphoplasty No overall conclusions can be drawn with respect to comparative safety and effectiveness in osteoporosis between verebroplasty and kyphoplasty.

Project Status: Completed

Year Published: 2011

URL for published report: https://www.researchgate.net/profile/James_Doidge/publication/299977746_Review_of_interim_funded_service_Vertebroplasty_and_new_review_of_Kyphoplasty_MSAC_Reference_271_Assessment_Report/links/570781c308ae04e9708ea2d3/Review-of-interim-funded-service-Vertebroplasty-and-new-review-of-Kyphoplasty-MSAC-Reference-271-Assessment-Report.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Adelaide Health Technology Assessment

Contact Address: School of Public Health, Mail Drop 545, University of Adelaide, Adelaide SA 5005, AUSTRALIA, Tel: +61 8 8313 4617

Contact Name: ahta@adelaide.edu.au

Contact Email: ahta@adelaide.edu.au

Copyright: Adelaide Health Technology Assessment (AHTA)