gms | German Medical Science

Objective: Degenerative disc disease (DDD) is believed to be the major cause of low back pain (LBP). While most of the patients suffering from discogenic low back pain can be successfully treated by conservative means, non-responding patients often seek surgery which would consists of fusion or total disc arthroplasty (TDA). Both fusion and TDA are relatively aggressive treatments, and therefore effort has been directed toward the development of less invasive methods resulting in the NUBAC disc arthroplasty system. This is an ongoing, prospective, non-randomized, multicenter study evaluating the clinical results with the NUBAC disc arthroplasty system. This abstract specifically describes the German and Italian experience with the NUBAC.

Methods: Patients, who have discogenic LBP with or without leg pain and 6 months of failed conservative treatment are included in this longitudinal study. Patient pathology and surgeon preference determine which surgical approach, anterolateral, lateral or posterior, is used to implant NUBAC. Patient demographics, VAS and ODI are collected pre-operatively and at 6 weeks, 3, 6 and 12 months after operation. Enrollment is ongoing, data from the patients enrolled between April 2006 and November 2007 are presented.

Results: Worldwide over 150 devices have been implanted and the 2-year results are known. In Germany and Italy over 75 devices were implanted and a subset of the patients (n=53) were studied closely. The majority of the treated levels lie between L4-S1 (83%). Mean age is 42.2 years (26-70 years). The distribution of sexes is almost equal (females: 44.0%). The average operating time is 85 minutes and the average EBL is 36 ml. In respect to the operative approach, 38% had the posterior approach, 56% the lateral one, and 6% were operated by the anterolateral approach. No major intra-operative neurological or vascular complications occurred for any of the used approaches. Pain relief is assessed by VAS and function by the ODI. Pre-operative VAS score was 75.5 and improved to 26.8, 24.5, 21.4 and 26.6 at 6 weeks, 3, 6 months and 1 year, respectively. ODI showed continuous improvement at all visits with improvement of the pre-operative score (51.8) to 22.8, 18.1, 20.9 and 17.9 at 6 weeks, 3, 6 months and 1 year, respectively.

Conclusions: The data demonstrate that NUBAC is a less invasive treatment option which is effective in relieving pain and improving function and is clinically suitable for all three major surgical approaches.