Comparison of Clinical Outcomes of 1- and 2-Level Total Disc Replacement. Issue 11 (1st June 2015)

• Record Type: Journal Article
• Authors: Bae, Hyun W.; Kim, Kee D.; Nunley, Pierce Dalton; Jackson, Robert J.; Hisey, Michael S.; Davis, Reginald J.; Hoffman, Gregory A.; Gaede, Steven E.; Danielson, Guy O.; Peterson, Daniel L.; Stokes, John M.; Araghi, Ali
• Is Part Of: Spine. Volume 40:Issue 11(2015)
• Publication Date: 2015-06-01
• Subjects: Spine -- Abnormalities -- Periodicals; Spine -- Diseases -- Periodicals; Spine -- Surgery -- Periodicals; 616.73005
• DOI: 10.1097/BRS.0000000000000887
• Languages: English
• ISSNs: 0362-2436

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <sec> <title>Study Design.</title> <p>A prospective, randomized, multicenter Food and Drug Administration Investigation Device Exemption study using total disc replacement as surgical treatment of degenerative disc disease at 1 or 2 contiguous levels of the cervical spine.</p> </sec> <sec> <title>Objective.</title> <p>To evaluate the safety and effectiveness of total disc replacement at single or 2 contiguous levels through 48 months of follow-up.</p> </sec> <sec> <title>Summary of Background Data.</title> <p>Cervical total disc replacement has been shown to be a safe and effective alternative to anterior cervical discectomy and fusion at 24 months. Its motion-preserving capabilities may avoid accelerating adjacent segment pathology and thereby lower the rate of associated complications.</p> </sec> <sec> <title>Methods.</title> <p>Patients were randomized in a 2:1 ratio (total disc replacement [TDR]: anterior cervical discectomy and fusion [ACDF]) at 24 sites. Ultimately, 164 patients received TDR at 1 level and 225 patients received TDR at 2 contiguous levels. An additional 24 patients (15 one-level, 9 two-level) were treated with TDR as training cases.</p> <p>Outcome measures included neck disability index, visual analogue scale neck and arm pain, Short Form 12-item Health Survey (SF-12) Mental Composite Score (MCS) and Physical Composite Score (PCS), range of motion, major complication rates, and secondary surgery rates. Patients received follow-up examinations at regular intervals through 4 years after surgery.</p> </sec> <sec> <title>Results.</title> <p>Preoperative characteristics were statistically similar for the 1- and 2-level patient groups. Four-year follow-up rates were 83.1% (1-level) and 89.0% (2-level). There was no statistically significant difference between 1- and 2-level TDR groups for all clinical outcome measures. Both TDR groups experienced significant improvement at each follow-up when compared with preoperative scores. One case of migration was reported in the 2-level TDR group.</p> </sec> <sec> <title>Conclusion.</title> <p>A 4-year <italic>post hoc</italic> comparison of 1- and 2-level TDR patients concurrently enrolled in a 24-center, Food and Drug Administration Investigation Device Exemption clinical trial indicated no statistical differences between groups in clinical outcomes, overall complication rates, and subsequent surgery rates.</p> <p> <bold>Level of Evidence:</bold> 1</p> </sec> </abstract>