Five-Year FDA IDE Trial Outcomes Show a Higher Safety Profile and Greater Effectiveness at Preserving Range of Motion for the activL® Artificial Disc Compared to Previous Generation Lumbar Discs

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Aesculap Implant Systems, LLC, 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.

“The data gathered from the study displays the impact of maintaining the motion of a healthy spine on patients’ quality of life. It is promising to see the technology of artificial discs continuing to improve upon previous generations with more effective and safer results,” said James J. Yue, MD of Midstate Medical Center/Quinnipiac School of Medicine and activL IDE Trial co-lead investigator. “I am pleased to be able to offer my patients a trusted alternative to fusion.”

At five years, 95% of the activL Artificial Disc patients were reoperation free in comparison to fusion, which is associated with a 10-15% risk of reoperation in the same period of time. Supported by a recent indirect comparison of TDR patients from the activL IDE study and lumbar fusion patients from Zigler and Delamarter (2012), preserving the intended motion of the spine may reduce risk of ASD compared to lumbar fusion. Patients with a greater improvement in degrees of ROM at the TDR level were less likely to have radiographic adjacent level degeneration, as described in a post-hoc analysis of this five year activL Artificial Disc study.

“Aesculap continuously strives to provide patients with innovative technologies. With the publication of the long-term outcomes from our randomized control trial, surgeons and patients alike can be confident in the clinical outcomes when using the activL Artificial Disc,” said Chuck DiNardo, President of Aesculap Implant Systems. “We are hopeful that the five-year data presented in this publication will provide the evidence needed to give DDD sufferers in this specific patient population widespread access to Total Disc Replacement.”

The full text can be found on the Spine website: https://journals.lww.com/spinejournal/Abstract/publishahead/Five_year_Results_of_a_Randomized_Controlled_Trial.94562.aspx

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