Cervical arthroplasty with ROTAIO® cervical disc prosthesis: first clinical and radiographic outcome analysis in a multicenter prospective trial

BACKGROUND: Cervical Disc Arthroplasty (CDA) seems to be an alternative to Anterior Cervical Decompression and Fusion (ACDF) and was developed to minimize the risk of Adjacent Segment Disease (ASD). The ROTAIO Cervical Disc Prosthesis represents a new unconstrained implant with a variable centre of rotation which should enable physiological facet-guided movement. The aim of this current study was to evaluate the clinical outcomes after arthroplasty using ROTAIO Cervical Disc Prosthesis. METHOD: Twenty-seven female and 18 male patients (n = 45) with a mean age of 43.7 ± 7.8 years were prospectively followed up for a maximum of 24 month. Clinical outcomes were assessed by Neck Disability Index (NDI), visual analogue scale (VAS) scores for neck and arm pain, patients´ overall satisfaction and the usage of analgesics. Additionally, radiographic information including ROM of the functional spinal unit (FSU) and signs of adjacent segment disease were recorded. RESULTS: NDI and VAS scores showed significant improvement 6 months after surgery and at last follow-up (p < 0.001). Concerning overall satisfaction 95.7 % of the patients showed good to excellent results at the last visit and a significant reduction of analgesic usage was observed (p < 0.001). Radiographic measurements showed a mean increase of ROM up to 8.40° in the treated FSU at last follow-up (p < 0.001). No signs of anterior migration or dislocation of the prosthesis and no subsidence was recorded radiographically. There were no major complications and a low rate of secondary procedures (2.2 %). CONCLUSION: In the 24-months follow-up the ROTAIO Cervical Disc Prosthesis provided excellent clinical and radiographical results and seems to be safe and effective for the treatment of symptomatic single-level degenerative disc disease.