Study Expands Clinical Evidence Supporting Centinel Spine’s prodisc L System

Centinel Spine LLC is touting landmark study data that support the long-term clinical success and durability of its prodisc L Lumbar Total Disc Replacement (LTDR) technology.¹ The study has been published in The Journal of Bone & Joint Surgery.

The retrospective study expands the evidence validating the fixed-core design of the prodisc L device and includes 1,187 patients who underwent LTDR surgery for chronic lumbar degenerative disc disease (DDD), making it one of the largest LTDR patient cohorts ever evaluated. The study was also one of the first of its kind to evaluate LTDR patients across such a long duration of follow-up—seven to 21 years (mean of 11 years and eight months). The trial’s goal was to evaluate the clinical outcomes of patients who underwent 1- or 2-level LTDR, as well as to evaluate patients with or without prior discectomy at the index level(s).

The study covered all eligible LTDR procedures performed at a single institution (Montpellier Spine Institute (CCV) Clinique du Parc, Castelnau-le-Lez, France) from 1999 to 2013, and included 772 patients who underwent a 1-level LTDR procedure and 415 who underwent a 2-level procedure. Three hundred seventy-three patients had prior discectomy surgery.

According to long-term results, there was statistically equivalent improvement in outcomes for 1-level LTDR and 2-level LTDR, for patients both with and without prior discectomy surgery. The study also demonstrates the robust long-term clinical success and implant survivorship of prodisc L through an extremely low index revision rate of 0.67%. Additionally, a low adjacent-level surgery rate of 1.85% confirmed the prodisc L design coupled with LTDR mobility restoration supports long-term preservation of adjacent levels.

The lead author of the study is French orthopedic spine surgeon Thierry Marnay, M.D., who invented the prodisc lumbar technology as a motion-sparing alternative to fusion. “Total disc replacement, and especially the prodisc technology, is a concept we started to develop in the 1980s. This study was conducted with the clinical team in Clinique du Parc Montpellier over the last 25 years,” Dr. Marnay said. “The quality and the robustness of its results are a major achievement that fundamentally confirms the long-term efficiency and safety of LTDR through an anterior approach and the positive clinical results for patients after surgery with prodisc L. It is no longer possible to ignore the fundamental positive outcomes through the preservation and/or restoration of spine mobility. There is a direct link between this recovered, pain-free mobility and everyday quality of life.”

The prodisc L technology has been proven after nearly 35 years of clinical use and more than 125,000 devices implanted worldwide.² The prodisc L LTDR system now includes U.S. Food and Drug Administration approvals for one-level indications, two-level indications and, most recently, for Anatomic Endplate versions of the implant.

Centinel Spine LLC is exclusively focused on addressing cervical and lumbar spinal disease with prodisc, the most complete total disc replacement (TDR) technology platform in the world.

The Company’s prodisc technology is the most studied and clinically-proven TDR system globally, validated by over 540 published papers and more than 250,000 implantations. Centinel Spine’s prodisc is the only TDR technology with multiple motion-preserving anatomic solutions, allowing the surgeon to Match-the-Disc to each patient’s anatomy for both cervical and lumbar total disc replacement, according to the company.

References
¹ Marnay, Thierry P.; Geneste, Guillaume Y.; Edgard-Rosa, Gregory W.; Grau-Ortiz, Martin M.; Hirsch, Caroline C.; Negre, Georges G. Clinical Outcomes After 1 and 2-Level Lumbar Total Disc Arthroplasty: 1,187 Patients with 7 to 21-Year Follow-up. November 22, 2024. J Bone Joint Surg Am. 2024;00:1-13. http://dx.doi.org/10.2106/JBJS.23.00735
² Data on file for prodisc L.