Lumbar Total Disc Replacement Device Removals and Revisions Performed During a 20 Year Experience with 2,141 Patients.

STUDY DESIGN:This was a retrospective study with prospective patient contact attempted to collect current data. OBJECTIVE:The purpose was to investigate the incidence and reasons for lumbar total disc replacement (TDR) removal or revision. SUMMARY OF BACKGROUND DATA:A concern regarding lumbar TDR was safety, particularly the need for device removal or revision. This may be particularly important considering removal/revision requires repeat anterior exposure with increased risk of vascular injury. METHODS:Data were collected for a series of 2,141 lumbar TDR patients beginning with the first case experience in 2000. Mean follow-up was 78.6 months. For each case of device removal/revision, the reason, duration from index surgery, and procedure performed were recorded. RESULTS:Of 2,141 patients, 27 (1.26%) underwent TDR removal or revision. Device removal was performed in 24 patients (1.12%) while 3 patients underwent revision (0.14%). Of the 24 removals: 12 were due to migration and/or loosening, 3 developed problems post-trauma, 2 developed lymphocytic reaction to device materials, 2 had ongoing pain, and there was one case of each: TDR was too large, vertebral body fracture (osteoporosis), lytic lesion, device subsidence and facet arthrosis, and infection seeded from a chest infection 146 months post-TDR. The 3 revisions were for: Core repositioning (technique error), device repositioning after displacement, and core replacement due to wear/failure. With respect to timing, 37.0% of removals/revisions occurred within one month post-implantation. Of note, 40.7% of removals/revisions occurred in the first 25 TDR cases performed by individual surgeons. There was one significant vascular complication, occurring in a patient whose TDR was removed due to trauma. This was also the only patient among 258 with >15-year follow-up who underwent removal/revision. CONCLUSION:In this large consecutive series, 1.26% of TDRs were removed/revised. The low rate over a 20 year period supports the safety of these devices.