RT Journal Article
SR Electronic
T1 Clinical performance of an elastomeric lumbar disc replacement: Minimum 12 months follow-up
JF International Journal of Spine Surgery
JO Int J Spine Surg
FD International Society for the Advancement of Spine Surgery
SP 16
OP 25
DO 10.1016/j.esas.2009.12.002
VO 4
IS 1
A1 Luiz Pimenta
A1 Raul Springmuller
A1 Casey K. Lee
A1 Leonardo Oliveira
A1 Sandra E. Roth
A1 William F. Ogilvie
YR 2010
UL https://www.ijssurgery.com/content/4/1/16.abstract
AB Background Elastomeric disc replacements have been developed to restore normal shock absorption and physiologic centers of rotation to the degenerated disc. The Physio-L Artificial Lumbar Disc is an elastomeric disc which uses a compliant polycarbonate-polyurethane core with enhanced endurance properties. The objective of this study was to evaluate the safety and efficacy of the Physio-L through a 12-month follow-up period in a prospective, nonrandomized clinical trial.Methods Twelve patients who met the inclusion/exclusion criteria were enrolled in the study. Eight patients received a single implant (L5-S1) and 4 received a 2-level implantation (L4-5 and L5-S1). Patients were assessed preoperatively and postoperatively at 6 weeks and 3, 6, and 12 months. Primary outcomes included the VAS, ODI, a radiographic analysis of implant condition, incidence of major complications, and reoperations. Secondary outcomes included SF-36, ROM at index and adjacent levels and disc height.Results All patients completed the 12-month follow-up evaluations. Through 12 months, the Physio-L devices have remained intact with no evidence of subsidence, migration, or expulsion. VAS low-back pain and ODI scores improved significantly at all follow-up periods compared to preoperative scores. The range of motion of 13.3° ± 5.5° at the index level was considered normal. Overall, patients were satisfied with an average score of 83.5 ± 26.8 mm. When comparing the device to other artificial discs, the current device showed a clinically relevant improvement in both ODI and VAS scores at all follow-up time points. Statistically significant improvements in both scores were observed at 12 months (P < .05).Conclusion The Physio-L is safe and efficacious, as demonstrated by improved pain relief and functional recovery without any implant failures, significant device related complications, or adverse incidents. The clinical results for VAS and ODI were superior to other marketed artificial lumbar discs such as the Charité and ProDisc-L at the same follow-up timeframes.