A 5-year Follow-up of a Controlled Mobile Core Lumbar Disc Prosthesis: Clinical Results

Abstract

Purpose: Total disc replacement is an alternative to arthrodesis in degenerative disc disease in young patients suffering from persistent chronic back pain refractory to conservative treatments. 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. Methods: Four hundred and eleven patients were included in a prospective and multicenter study with 5-year follow-up. The clinical assessment investigated ODI, VAS (lumbar and radicular) score, quality of life (SF-36), medication consumption, professional status, and complication occurrence after surgery. Results: ODI significantly decreased at 5 years after surgery with an average improvement of 27.3%. Low back pain and radicular pain significantly decreased. SF-36 significantly increased for both the mental and physical components. Medication consumption also significantly decreased at 5 years. Professional status was improved with an increase in the proportion of working patients and a decrease in sick leave up to 5 years after surgery. All complications were reported with an overall reoperation rate of 14.6% (regardless the cause and the level of the lumbar spine). Conclusion: This study showed satisfactory clinical results and patient satisfaction at 5 years’ follow-up and confirmed the safety and efficacy of this lumbar total disc prosthesis with specific controlled-mobility core.