Aesculap Implant Systems has announced the publication of seven-year results from a randomised controlled investigational device exemption (IDE) trial for lumbar artificial discs in single-level degenerative disc disease (DDD), which indicated that the activL artificial disc demonstrates prolonged significant improvements in back/leg pain, disability index and quality-of-life relative to baseline.
The study compared patient outcomes at seven years’ post-procedure, comparing the activL artificial disc, the latest generation lumbar total disc replacement (TDR), with the previous generation disc replacement system—ProDisc-L—in the treatment of patients with symptomatic single-level lumbar DDD.
Findings of the study, which were published in the International Journal of Spine Surgery (IJSS), also showed that activL artificial disc patients have significantly better range of motion for flexion-extension rotation than ProDisc-L patients (p=0.033) at seven years and that significantly fewer activL disc patients report serious safety issues than ProDisc-L patients (p=0.011).
Additionally, predictive modeling demonstrated that most patients lost to follow-up at two years have clinically significant benefits with the activL artificial disc at seven years if improvements are made at two years.
The activL artificial disc is designed to preserve motion at a single level (L4-L5 or L5-S1) of the spine by replicating the performance of the intact intervertebral disc. The long-term evidence from the FDA non-inferiority study presented in this paper supports lumbar TDR as a safe and effective treatment option for DDD, says Aesculap.
Kris Radcliff of the Rothman Orthopedic Institute (Philadelphia, USA), said: “This publication represents the longest follow-up of patients from a lumbar arthroplasty IDE Trial and proves without a doubt the safety and efficacy of lumbar disc arthroplasty. I am proud to offer my patients this technology as an alternative to fusion.”
Charles DiNardo, president of Aesculap Implant Systems, added: “Aesculap continues to see significant benefits toward quality of life with the activL Artificial Disc. The latest evidence of patient outcomes from our randomsed controlled trial demonstrates the long-term impact of the technology.
“We see first-hand the impact lumbar arthroplasty has in returning patients’ quality of life and are hopeful that the seven-year data presented in this publication will provide the long-term evidence needed to further improve access to patients with DDD.”