SWISSspine - a nationwide health technology assessment registry for balloon kyphoplasty: methodology and first results

BACKGROUND CONTEXT: The Swiss Federal Office of Public Health demanded a nationwide health technology assessment registry for cervical and lumbar total disc arthroplasty and for balloon kyphoplasty (BKP) to make a decision about reimbursement of these interventions. PURPOSE: The goal of the SWISSspine registry is to generate evidence about the safety and effectiveness of these technologies. We report on results of patients with balloon kyphoplasty. STUDY DESIGN/SETTING: Prospective, multicenter, observational case series. PATIENT SAMPLE: From March 2005 until June 2008, 331 interventions with 391 treated levels in 320 patients have been documented. 75.6% of patients were females with mean age of 74 years (range 43-95.2 years); mean age of males was 72.6 years (range 41.4-93 years). OUTCOME MEASURES: Surgeon-administered outcome instruments were primary intervention form for BKP, implant, and follow-up form; patient self-reported measures were Euroqol-5D, North American Spine Society, and a comorbidity questionnaire. METHODS: Data were recorded perioperative, at 3 months, 1 year, and annually thereafter. Wilcoxon signed-rank test was used for comparison of preoperative to postoperative measurements. Multivariate regression was used for identifying factors with a significant influence on the outcome. RESULTS: Significant and clinically relevant reduction of back pain, improvement of quality of life (QoL), and reduction of pain killer consumption were seen in the 1-year follow-up. Improvement of preoperative segmental kyphosis was achieved in the majority of cases. There were three symptomatic cement extrusions with radiculopathy documented. CONCLUSIONS: Balloon kyphoplasty is a safe and effective treatment concerning pain reduction, QoL improvement, and pain killer consumption. The SWISSspine registry proved to be an excellent tool for evaluation of this new technology, and its results, in combination with an elaborate health technology assessment report, led to a permanent coverage of BKP by the basic health insurance. (C) 2010 Elsevier Inc. All rights reserved.