ABSTRACT
PURPOSE: The purpose of this study was to assess the mid-term clinical and radiological results as well as patient safety in terms of complication and reoperation rates in patients treated with a novel anterior stand-alone fusion (ASAF) device (Synfix-LR, DePuy Synthes, West Chester, PA, USA) in a cohort of patients with predominant and intractable low back pain originating from monosegmental degenerative disc disease at the lumbosacral junction. METHODS: Clinical outcome scores visual analog scale (VAS), Oswestry disability index (ODI) and patient satisfaction rates were acquired within the framework of an ongoing single-center prospective clinical trial. Evaluation of radiological data included segmental and global lumbar lordosis, neuroforaminal height and width. Interbody fusion was assessed from post-operative CT scans. The minimum follow-up (FU) was 12 months. RESULTS: 71 out of an initial 77 patients were available for final FU (92.2 % FU rate) after a mean FU of 35.1 months (range 12.0-85.5 months). The overall results revealed a highly significant improvement from baseline VAS and ODI levels (p < 0.0001). 77.5 % (n = 55/71) of all patients reported a 'highly satisfactory' (n = 37/71; 52.1 %) or a 'satisfactory' (n = 18/71; 25.4 %) outcome; 22.5 % of patients were not satisfied. The overall complication rate was 12.7 % (n = 9/71). Two cases required post-operative revision surgery (2.8 %). Radiographical analysis demonstrated a highly significant increase of segmental lordosis from 16.1° to 26.7° (p < 0.0001). A high rate of solid interbody fusion was confirmed in 97.3 % of all cases (n = 36/37). CONCLUSION: The current study delineates satisfactory clinical results following ASAF at the lumbosacral junction. Patient safety was demonstrated with acceptable complication and low reoperation rates. Radiological data demonstrated a significant reconstruction of lordosis at the lumbosacral junction. Solid interbody fusion was achieved in 97.3 % of all cases in a highly selected cohort with optimal predisposition for fusion. ASAF may serve to avoid a variety of negative side effects for a considerable number of patients which, otherwise, would have been candidates for posterior instrumented fusion techniques.
