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Purpose: Total disc replacement must allow pain relief due to the resection of the painful disc, with preserving segmental mobility and function of the intervertebral joint. The aim of this study is to assess the efficacy and safety of a mobile-core lumbar prosthesis. This study reports both clinical (Part 1) and radiological (Part 2) assessments. Method: Four hundred and eleven patients were included in a prospective and multicentric study with a 5-year follow-up. Radiological performance included mobility and lordosis of implanted segments. The occurrence of heterotopic ossification and the impact of the surgery on adjacent discs (motion and radiological signs of degeneration) were also explored. Results: Restoration of segmental mobility (mean ROM=7.8 at 5 years), improvement and stabilization of lordosis as well as a reduced rate of heterotopic ossification were observed. Improvement of ROM in superior and inferior discs was observed but without hyper-mobility. Slight degeneration of superior and inferior discs was noted compared to preoperative status. The rate of reoperation on adjacent discs was low (3.2%). Conclusion: This study showed satisfactory radiological results by restoring motion and preserving adjacent segments at 5 years’ follow-up and confirmed the safety and efficacy of this lumbar total disc prosthesis with specific controlled-mobility core.

Radiological Results Five Years Following Lumbar Total Disc Replacement with a Controlled Mobile Core Prosthesis