A multicenter retrospective study of the clinical results of the LINK SB Charité intervertebral prosthesis. The initial European experience.

Abstract

This study is a multicenter, retrospective review of the initial clinical results of an artificial disc replacement, the LINK SB Charité intervertebral prosthesis. Independent analysis by chart review included patient demographics, surgical data, and a comparison of presurgical to follow-up data. Data were analyzed from 93 patients (average age = 43.0 +/- 7.3) in whom a total of 139 Model III prostheses (Waldemar Link GmbH & Co, Hamburg, Germany) were implanted. The predominant diagnostic indication for the disc was degenerative disc disease (52.4%). The L4-L5 and L5-S1 levels comprised 87.1% of all levels implanted. The average follow-up was 11.5 +/- 8.4 months. After disc implantation, a significant proportion of the patient sample experienced pain relief (P < 0.05). Improvements were also noted in pain intensity, walking distance, lumbar mobility, and the percentage of patients showing a positive SLR or neurological weakness. No difference in work status after disc implantation could be detected. Device failure, migration, or dislocation occurred in 6 of 93 (6.5%) patients. This study represents the largest multicenter case series of any functional artificial disc implantation. Carefully controlled, prospective studies that compare disc implantation and fusion are warranted.