Elastomeric Lumbar Total Disc Replacement: Clinical and Radiological Results With Minimum 84 Months Follow-Up.

BACKGROUND

Total lumbar disc replacement (TDR) devices have been designed to maintain motion, but both biomechanical and clinical data have indicated that a more controlled motion and additional load absorption in TDR would be beneficial. This work analyzed long-term results of an elastomeric disc (Physio-L) for degenerative lumbar conditions.

MATERIAL AND METHODS

This was a prospective, noncomparative, single-center clinical and radiological study. A total of 15 patients with predominant low back pain due degenerative disc disease received anterior total disc replacement with a Physio-L disc. Clinical outcomes were assessed both with a visual analog scale for pain and Oswestry Disability Index questionnaires. Radiological outcomes included implant failure, range of motion (ROM), facet degeneration, and adjacent level disease. Complication and reoperation rates were also recorded. The cases were assessed with a minimum follow-up of 84 months.

RESULTS

A total of 15 patients were enrolled (20 TDRs)-10 single-level cases (L5S1) and 5 two-level cases (L4L5/L5S1). After 84 months, clinical outcomes scores still demonstrated significant improvement compared with baseline ( < .001). Mean visual analog scale scores dropped from 7.1 to 2.9, and the Oswestry Disability Index improved from 50 to 16. No disc has experienced migration or breakage. The average range of motion value went from a baseline of 12.0° to 13.3° at 12 months, and at the final follow-up it decreased to 9.9°. Regarding the double-level cases, 3 of 5 (60%) had adverse events; just 1 single-level (10%) had adverse events. At final follow-up, radiological signs of facet degeneration were present in 7 of 15 patients (47%) but with only 1 of 15 (6.7%) symptomatic. Two patients (13%) required surgery at the adjacent level. At the 84-month follow-up, 16 of 18 prostheses (89%) were still active (2 revised to fusion and 2 were lost to follow-up).

CONCLUSION

The long-term follow-up data shows satisfactory clinical results for the use of Physio-L elastomeric TDR in the treatment of degenerative disc disease. Studies with bigger cohorts are needed to replicate results and add new information regarding other details.