Landmark Lumbar Total Disc Replacement Study of Nearly 1,200 Patients Supports Long-term Clinical Success & Durability of Centinel Spine’s prodisc® L System

Large Patient Cohort

This retrospective study expands the evidence validating the fixed-core design of the prodisc L device and includes 1,187 patients that underwent LTDR surgery for chronic lumbar degenerative disc disease (DDD), making it one of the largest LTDR patient cohorts ever evaluated.

Significant Duration

The study was also one of the first of its kind to evaluate LTDR patients across such a long duration of follow-up—7 to 21 years (mean of 11 years and 8 months). The goal of the study 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).

Study Details

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 that underwent a 1-level LTDR procedure and 415 that underwent a 2-level procedure. A total of 373 of the patients had prior discectomy surgery.

Study Results

The long-term results of the study found:

• Statistically equivalent improvement in outcomes for 1-level LTDR and 2-level LTDR
• Statistically equivalent improvement in outcomes for patients both with and without prior discectomy surgery
• Low index-level revision rate of 0.67%
• Low adjacent-level surgery rate of 1.85%