activL® Artificial Disc Scientific Evidence

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Seven-Year Results

Radcliff et al., (2021) provided long-term evidence demonstrating that the activL Artificial Disc is more effective at preserving range of motion (ROM) and has a higher freedom from serious adverse events through seven years. Preservation of the motion of the spine through the implantation of a Lumbar Total Disc Replacement (TDR) is safe and effective for the treatment of single-level Degenerative Disc Disease. This paper demonstrates the continued safety and effectiveness of Lumbar TDR, with the longest follow-up from a Lumbar TDR IDE Trial published to date.

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Five-Year Results

Yue JJ et al., (2019) demonstrated through long-term evidence that the activL Artificial Disc has shown to be effective at preserving range of motion and has a higher freedom from serious adverse events through five years.

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Additional Evidence

Ziger, Jack E. MD; Blumenthal, Scott L. MD; Guyer, Richard D. MD; Ohnmeiss, Donna D. Dr. Med; Patel, Leena PhD. Spine: October 15, 2018 - Volume 43 - Issue - p 1395-1400 dol: 10.1097/BRS.0000000000002647

Fusion is associated with high rates of adjacent-level (ALD) degeneration in symptomatic lumbar disc degeneration. Lumbar total disc replacement (TDR) may reduce this risk. Zigler, et al., (2018) found TDR had a significantly lower rate of ΔALD than fusion. For each degree of range of motion gained at the lumbar TDR level, there was a consistent decrease in the percentage of patients with ΔALD.

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Domagoj Coric MD, Jack Zigler MD, Peter Derman MD, MBA, Ernest Braxton MD, MBA, Aaron Situ MSc, MQF, and Leena Patel PhD. Journal of Neurosurgery: October 8, 2021, pp. 1-9. dol: 10.3171/2021.5.SPINE21192

Long-term outcomes of single-level lumbar arthroplasty are understood to be very good, with the most recent Investigational Device Exemption (IDE) trial showing a < 5% reoperation rate at the close of the 7-year study. This post hoc analysis was conducted to determine whether specific patients from the activL IDE data set had better outcomes than the mean good outcome of the IDE trial, as well as to identify contributing factors that could be optimized in real-world use.

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Yue J, Garcia R, Miller L. Medical Devices: Evidence and Research. 9(2016): 75-84.

Yue et al., (2106) confirm that the biomechanical and clinical experience with the activL Artificial Disc is a more precise anatomical match than predicate lumbar prosthesis.

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Gornet M, Burkus K, Dryer R, Peloza J. Spine. 36. 25(2011): E1600-E1611.

Patients with single level degenerative disc disease (DDD) who are unresponsive to conservative care require surgical intervention. Gornet et al., (2011) demonstrated that lumbar total disc replacement is statistically superior to fusion in the treatment of single-level (DDD) at 24 months (p<0.001). 

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Zigler J, Delamarter R. Journal of Neurosurgery. 17. 6(2012): 493-501.

Fusion has traditionally been the standard of care for single level degenerative disc disease (DDD). Unlike fusion, total disc replacement (TDR) preserves the biomechanics of a healthy spinal segment. Zigler et al., (2012) demonstrated at five years, Lumbar TDR was found to be non-inferior to fusion (53.7% vs. 50.0%; p=0.0099).

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