Abstract
Purpose: SWISSspine is a national health technology assessment (HTA) registry for ballon kyphoplasty (BKP) and total disc arthroplasty (TDA). It was initiated to evaluate the safety, efficiency and cost-effectiveness of these products. It is the first mandatory orthopaedic HTA registry of its kind in Switzerland. The aim is to generate evidence for a decision about reimbursement by the Swiss basic health insurance.
Methods: During the time between March 2005 until June 2008, 331 interventions with 391 treated levels in 320 patients have been documented. Data was collected in a prospective, observational multicenter mode. The preliminary timeframe for the registry is three years. Data collection is performed preoperative, at 6 weeks, 3 months, 6 months and 1 year followup as well as annually thereafter. Surgery and followup case report forms are administered by spinal surgeons. Comorbidity questionnaires, NASS and EQ-5D forms are completed by patients.
Results: Significant and clinically relevant reduction of back pain, improvement of quality of life and reduction of pain killer consumption was seen in the 1 year followup. Improvement of preoperative segmental kyhposis was achieved in the majority of cases. There were three symptomatic cement extrusions with radiculopathy documented.
Conclusion: BKP is a safe and effective treatment concerning pain reduction, quality of life improvement and pain killer consumption. The SWISSspine registry proved to be an excellent tool for evaluation of this new technology and its results lead to a permanent coverage of BKP by the basic health insurance.
Correspondence should be addressed to: EFORT Central Office, Technoparkstrasse 1, CH – 8005 Zürich, Switzerland. Email: office@efort.org
