Aesculap Implant Systems, LLC, a leader in lumbar motion preservation technology, today announced the e-publication of the “Five-year results of a randomized controlled trial for lumbar artificial discs in single level degenerative disc disease” in Spine. The five-year study reports the outcomes of 261 patients at five years post procedure comparing the activL Artificial Disc, the latest generation Lumbar Total Disc Replacement (TDR), with the previous generation disc replacement systems — ProDisc-L and Charité — in the treatment of patients with symptomatic single-level lumbar degenerative disc disease (DDD). Also, an indirect comparison of TDR patients with fusion patients provides further insight into the relationship between range of motion (ROM) and adjacent segment disease (ASD). The publication of this long-term data is pivotal in gaining acceptance and support of lumbar TDR as a standard of care for a specific patient subset.
The activL Artificial Disc is designed to preserve motion at the treated level of the spine by replicating the performance of the intact intervertebral disc. The long-term evidence from the FDA non-inferiority study presented in the paper supports lumbar TDR as a safe and effective treatment option for DDD. At five years, the activL Artificial Disc is shown to be more effective at preserving ROM compared to the first generation lumbar TDRs (ProDisc-L and Charité) and offers a higher safety profile.
In addition to the ROM superiority of the activL Artificial Disc when compared to Control, secondary outcomes show that at five years, the activL Disc was effective in reducing back pain, improving back function and increasing health-related quality of life. The chronic lower back pain caused by DDD can often lead to narcotic use by those affected. In fact, 64.7% of activL Disc patients were using narcotics at the time of surgery. At five years, the proportion of patients taking narcotics decreased to <2% in the study population.