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

Spine (Phila Pa 1976). 1994 Aug 15;19(16):1842-9. doi: 10.1097/00007632-199408150-00009.

Abstract

Objective: This study is a multicenter, retrospective review of the initial clinical results of an artificial disc replacement, the LINK SB Charité intervertebral prosthesis.

Methods: 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.

Results: 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.

Conclusions: 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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Chromium Alloys
  • Cohort Studies
  • Female
  • Follow-Up Studies
  • Humans
  • Intervertebral Disc Displacement / epidemiology
  • Intervertebral Disc Displacement / surgery*
  • Intervertebral Disc* / surgery
  • Lumbar Vertebrae / surgery*
  • Male
  • Polyethylenes
  • Prostheses and Implants*
  • Prosthesis Design
  • Prosthesis Failure
  • Retrospective Studies
  • Time Factors
  • Treatment Outcome

Substances

  • Chromium Alloys
  • Polyethylenes