Authors' objectives: This health technology assessment evaluates the effectiveness, safety, and cost-effectiveness of percutaneous vertebroplasty and percutaneous balloon kyphoplasty for adults with painful osteoporotic vertebral compression fractures. It also evaluates the budget impact of publicly funding percutaneous vertebroplasty and balloon kyphoplasty and the experiences, preferences, and values of people with painful osteoporotic vertebral compression fractures.

Authors' results and conclusions: RESULTS We included 10 studies in the clinical evidence review. Compared to conservative treatment (CT), there was significant (statistical and clinical) improvement in pain (up to 3 months follow-up, GRADE Low) and physical function (up to 6 months follow-up, GRADE Very low) for patients who underwent PVP. For PBK, there was significant (statistical and clinical) improvement in pain in the short term (up to 3 months follow-up, GRADE Very low) compared with CT. Overall, there were no significant differences for either PVP or PBK compared to conservative treatment for mortality, subsequent fractures or adverse events (GRADE Low to Very low). Cement leakage occurred in 4% to 39% of treated patients (PVP vs. CT, 4.0% [8/200 patients]; PVP vs. sham, 39.4% [9/99 patients]; PBK vs. CT, 4.5% [30/731 patients]) and most leakages were asymptomatic. The incremental cost-effectiveness ratio (ICER) of PVP compared with CT is $43,324 per quality-adjusted life-year (QALY) gained. The ICER of PBK compared with CT is $65,921 per QALY gained. The annual budget impact of publicly funding PVP and PBK in Ontario over the next 5 years ranges from an additional $0.5 million in Year 1 to $11.0 million in Year 5. The people we spoke to reported that their daily activities, work, social life, family relationships, and mental health were negatively impacted by OVCF. Those who underwent vertebroplasty reported a positive impact on pain relief and quality of life. CONCLUSIONS People who are refractory to first-line conservative treatment and who underwent PVP showed significant short-term clinical improvement in pain (GRADE Low) and physical function (GRADE Very low) compared to conservative treatment. Similarly, people who underwent PBK experienced significant short-term clinical improvement in pain (GRADE Very low) compared to conservative treatment. PVP and PBK were consistently more costly and more effective than CT. We estimate that publicly funding PVP and PBK in Ontario would result in additional costs of $28 million over the next 5 years. The insights shared by participants underscore the significant challenges individuals with OVCF face in managing their condition, with notable impacts on daily activities, work, social interactions, and mental health. Despite these challenges, participants highlighted the positive outcomes of vertebroplasty for those who underwent the procedure, particularly in terms of pain relief and improved quality of life.

Authors' recommendations: Ontario Health, based on guidance from the Ontario Health Technology Advisory Committee, recommends that percutaneous vertebroplasty and percutaneous balloon kyphoplasty be publicly funded and made accessible for appropriately selected patients with painful osteoporotic vertebral compression fractures.

Authors' methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the ROBIS tool for systematic reviews, the Cochrane Risk of Bias tool for RCTs, and the ROBINS-I tool for observational studies and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a 3-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding PVP and PBK in adults with painful OVCFs in Ontario. To contextualize the potential value of PVP and PBK, we spoke with people with OVCF.

Project Status: Completed

URL for project: https://ontariohealth.ca/system/health-innovation-pathway/reviews/hta-details?cf=vertebroplasty-kyphoplasty-osteoporotic-vertebral-compression-fractures

URL for protocol: https://www.crd.york.ac.uk/PROSPERO/view/CRD42024557272

Year Published: 2025

URL for published report: https://pmc.ncbi.nlm.nih.gov/articles/PMC12425451/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Ontario

Pubmed ID: 40950842

Organisation Name: Ontario Health

Contact Address: 525 University Ave, Toronto, ON M5G 2L3

Contact Name: HealthInnovationPathway@ontariohealth.ca

Contact Email: HealthInnovationPathway@ontariohealth.ca

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