General Session: Cervical Motion Preservation
Presented by: L. Pimenta - View Audio/Video Presentation (Members Only)
L. Pimenta(1,2), L. Marchi(1), L. Oliveira(1), J. Nogueira-Neto(1), E. Coutinho(1), R. Amaral(1)
(1) Instituto de Patologia da Coluna, Sao Paulo, Brazil
(2) UCSD, Neurosurgery, San Diego, CA, United States
Background: Total lumbar disc replacement (TDR) devices have been designed to maintain motion but results have indicated that additional load absorption would be beneficial. This work analyzed long-term results of Physio-L®, an elastomeric disc, for degenerative lumbar conditions.
Material and Methods: Prospective, non-comparative, single center case series clinical study. Fifteen patients with predominant low back pain due degenerative disc disease received anterior disc replacement with the Physio-L® disc. Clinical outcomes were assessed both with VAS for pain and ODI questionnaires. Radiological outcomes included with implant condition, ROM, facet degeneration and adjacent level disease. Complication and reoperation rates were also recorded. The cases were assessed with minimum 84 months.
Results: Fifteen cases enrolled (total 20 TDRs; average age 37 years old). Ten cases received treatment at a single level (L5-S1) while five cases at two levels. After 86 months, clinical outcomes scores maintained statistical significant improvement compared to baseline (p< 0.001). Mean VAS scores dropped from 7.1 to 2.9, and ODI improved from 50 to 16. Any TDR experienced migration or breakage. ROM average went from a baseline of 12.0° to 13.3° at 12mos, and at the final follow-up was 9.9°. From the double-level cases, 3/5(60%) had adverse events, and from the 10 single-level, just 1 case (10%) had adverse events. Radiological signs of facet degeneration (hypertrophy/narrowing) were present in 7/15 levels(47%) but with only 1/15(6.7%) symptomatic. Two cases (13%) required surgery at adjacent level. At 84-month follow-up, 16 from 18 prostheses (89%) were still active (2 revised to fusion, and 2 missed last follow-up).
Conclusion: The long-term follow-up data shows encouraging safety and 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.
Prostheses survival curve