Abstract
Background: Due to reported high rates of complications in Total Disc Replacement Swiss health care system demanded an obligatory national Health Technology Assessment-registry for Total Disc Replacement. Thus, SWISSspine was founded in 2003 to assess efficiency, cost effectiveness, safety and find predictors of co-morbidity for surgical outcome.
Study design and Methods: In an observational multi center mode data were collected from March 2005 to August 2008 with detailed frequency statistics. Preoperative assessment, 3 month and 1 year FU using EQ-5D, NASS-Instrument and co-morbidity-forms for patients were applied. The surgeons administered OR- and FU-forms. Statistics: multivariate regression analysis.
Patient sample: 427 interventions with 497 implants.
Results: A significant reduction of back pain: 71 to 31 (p< 0.001) and leg pain 54.7 to 20.7 (p< 0.001) was documented (VAS, 1year postop). Quality of life measured in EQ-5D increased from 0.32 to 0.73. Opiate-usage decreased from 31.7% to 7.7%. Increasing ROM and re-established lordosis were seen. Overall 19 complications occurred, 12 revisions were performed. It was revealed that medicamentous treated depression had a negative influence on the outcome.
Conclusions: SWISSspine as a mandatory instrument was successfully implemented in the treatment-program of degenerative lumbar disc-diseases. The results provide evidence for patients benefit. Back- as well as leg pain was reduced. Complication- and revision rates were low. Medicamentous treated depression seems to have a negative influence on postoperative pain outcome in TDR. Our results obtained from SWISSspine provide a reasonable potential supporting surgeon in decision making for TDR especially in patients with medicamen-tous treated depression.
Correspondence should be addressed to: EFORT Central Office, Technoparkstrasse 1, CH – 8005 Zürich, Switzerland. Email: office@efort.org
