Lumbar Total Disk Replacement Device Removals and Revisions Performed During a 20-Year Experience with 2141 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 disk 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 an increased risk of vascular injury. Methods. Data were collected for a series of 2141 lumbar TDR patients, beginning with the first case experience in 2000. The 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 2141 patients, 27 (1.26%) underwent TDR removal or revision. Device removal was performed in 24 patients (1.12%), while three patients underwent revision (0.14%). Of the 24 removals, 12 were due to migration and/or loosening, three developed problems post-trauma, two developed lymphocytic reaction to device materials, two 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 three 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. [ABSTRACT FROM AUTHOR]