Centinel Spine, a spinal health-focused medical device firm, has announced results from a new study supporting the long-term success and durability of its prodisc L Lumbar Total Disc Replacement (LTDR) technology.
The large-scale retrospective study further validates the fixed-core design of the prodisc L device.
It 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 studied.
The study spans a follow-up period of seven to 21 years, with a mean follow-up of 11 years and eight months.
It evaluates the clinical outcomes of patients who received 1- or 2-level LTDR, including those with or without prior discectomy at the index level(s).
The study at the Montpellier Spine Institute (CCV) Clinique du Parc in France examined LTDR procedures performed between 1999 and 2013.
It included 772 patients who underwent 1-level LTDR and 415 patients who had 2-level LTDR, with 373 patients having prior discectomy surgery.
According to the long-term results, the device showed statistically equivalent improvement for both 1-level and 2-level LTDR, regardless of whether patients had prior discectomy.
The study highlights prodisc L’s strong long-term clinical success and implant survivorship of prodisc L through a low index revision rate of just 0.67%.
Additionally, the adjacent-level surgery rate was only 1.85%, demonstrating that the prodisc L design and LTDR mobility restoration effectively preserve adjacent spinal levels over time.
Study lead author and French orthopaedic spine surgeon Thierry 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 available for nearly 35 years of clinical use, with more than 125,000 devices implanted worldwide.
The prodisc L LTDR system is US Food and Drug Administration (FDA)-approved for 1-level and 2-level indications, and most recently, for the Anatomic Endplate version of the implant.
Last month, Centinel Spine announced the first US implantation of its FDA-cleared prodisc C Nova cervical total disc replacement (TDR) product.
