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

Diel, Peter; Reuss, Wolfgang; Aghayev, Emin; Moulin, Patrick; Röder, Christoph; SWISSspine Registry Group,

doi:10.1016/j.spinee.2009.08.452

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Volume 10, Issue 11 , Pages 961-971, November 2010

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

Peter Diel, MD
- Institute for Evaluative Research in Orthopaedic Surgery, University of Bern, Stauffacherstrasse 78, CH-3014 Bern, Switzerland
Wolfgang Reuss, MD
- Institute for Evaluative Research in Orthopaedic Surgery, University of Bern, Stauffacherstrasse 78, CH-3014 Bern, Switzerland
Emin Aghayev, MD
- Institute for Evaluative Research in Orthopaedic Surgery, University of Bern, Stauffacherstrasse 78, CH-3014 Bern, Switzerland
- Corresponding author. Institute for Evaluative Research in Orthopaedic Surgery, University of Bern, Stauffacherstrasse 78, CH-3014 Bern, Switzerland. Tel.: (31) 631-5940; fax: (31) 631-5931.
Patrick Moulin, MD
- Swiss Paraplegic Center Nottwil, Guido A. Zäch Strasse 1, 6207 Nottwil, Switzerland
Christoph Röder, MD
- Institute for Evaluative Research in Orthopaedic Surgery, University of Bern, Stauffacherstrasse 78, CH-3014 Bern, Switzerland
- Spine Service Inselspital Bern, University Hospital, University of Bern, Stauffacherstrasse 78, CH-3014 Bern, Switzerland
SWISSspine Registry Group

Received 7 April 2009; received in revised form 14 July 2009; accepted 26 August 2009. published online 12 October 2009.

Abstract

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.

Keywords: Balloon kyphoplasty, Health technology assessment, Osteoporosis, Registry, Vertebral fracture, SWISSspine