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.

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.

Introduction: To date, herniated nucleus pulposus (NP) with radiculopathy and central or lateral recess stenosis are considered as contraindications for lumbar disc arthroplasty. In the present study we used data from a unique mandatory spine register, SWISSspine to investigate associations between preoperative status of NP herniated/non herniated with presence/absence of sciatica and clinical outcome

Methods: Between 3/2005 and 8/2008, 358 mono-segmental lumbar total disc arthroplasties were documented in a prospective observational multicenter mode. The data collection included peri-operative data and clinical outcomes based on NASS, EuroQol and VAS. The patients were divided into 4 groups: group I-128 patients with herniated NP with sciatica, group II-48 patients with herniated NP without sciatica, group III-74 patients without herniated NP but with sciatica and group IV-108 patients without herniated NP and no sciatica (classic indication). The groups were pair wise compared regarding 1-year postoperative VAS, EuroQol and NASS scores using ANOVA-test with Boferroni-Holm adjustment (α=0.05)

Results: The 4 groups had similar demographic characteristics. Statistical analyses showed no significant outcome differences between the classic and the other indications. For example a outcomes for group IV: NASS back pain pre-post: 72.0/31.7 EQ-5D pre-post: 0.32/0.69.

Discussion and Conclusion: Our analysis revealed no differences between patients with herniated NP combined with neural compression and patients with stenosis of recesses regarding pain alleviation and QoL improvement. The findings suggest that these diagnoses may not have to be considered as absolute contraindications for TDR anymore. The results of this multicenter observational study however, need to be verified in a controlled or experimental study design.