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Long-Term Clinical Outcomes With the Activ-L Lumbar Arthroplasty System
Jean-Paul Bryant1, John Paul G Kolcun2, G Damian Brusko1
1Department of Neurological Surgery, University of Miami Miller School of Medicine, Miami, Florida.
Background:
Low back pain (LBP) due to degenerative disc disease (DDD) is the most common occupational disorder worldwide. Lumbar total disc replacement (LTDR) has provided an alternative to rigid fusion to relieve pain with less motion restriction. We present clinical results with long-term follow-up from a single-center, single-surgeon series of patients treated with the Activ-L artificial disc.
Methods:
Thirty-three patients with symptomatic single-level DDD who failed nonsurgical therapy for a minimum of 6 months underwent single-level arthroplasty with the Activ-L system between 2007 and 2012. Demographic, preoperative, and postoperative data were collected prospectively. Clinical factors reviewed included occupational status, sensory deficits, functional status determined by Oswestry Disability Index (ODI), back pain, leg pain, pain medication consumption, and radiographic imaging.
Results:
Average age at surgery was 38.0 ± 7.8 years, and the majority of patients were male (60.6%). Average follow-up was 2.7 ± 1.7 years. Average ODI at preoperative baseline was 54.6 ± 13.5, with scores significantly improved at 6 weeks (28.6 ± 17.4, P < .0001), 3 months (24.1 ± 16.8, P < .0001), 6 months (22.3 ± 16.3, P < .0001), 1 year (18.8 ± 15.3, P < .0001), and final follow-up (15.6 ± 16.4, P < .0001). Most patients (87.8%) reported pain medication usage within 14 days of baseline evaluation, with consumption decreasing significantly at 1-year (34.5%, P < .0001) and long-term follow-up (21.2%, P < .0001). One patient experienced mild unilateral graft subsidence at 1 year, which remained stable on radiographs at 5 years. None of the prostheses required revision surgery.
Conclusions:
The Activ-L disc replacement system is safe and effective for treating single-level lumbar DDD. Patients reported significant improvement in functional outcomes and decreases in pain medication consumption. Further investigation of the Activ-L system in larger populations is warranted.
Clinical Relevance:
LBP is a common cause of disability worldwide, and better treatment options are needed to improve outcomes, including pain and mobility. Spine surgeons may choose the Activ-L disc replacement as a safe and effective treatment for LBP caused by single-level lumbar DDD.
