The spine journal : official journal of the North American Spine Society
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Randomized Controlled Trial Multicenter Study Comparative Study
Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease.
Cervical total disc replacement (TDR) is intended to address radicular pain and preserve functional motion between two vertebral bodies in patients with symptomatic cervical disc disease (SCDD). ⋯ The results of this clinical trial demonstrate that ProDisc-C is a safe and effective surgical treatment for patients with disabling cervical radiculopathy because of single-level disease. By all primary and secondary measures evaluated, clinical outcomes after ProDisc-C implantation were either equivalent or superior to those same clinical outcomes after Fusion.
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Multicenter Study
Do 1-year outcomes predict 2-year outcomes for adult deformity surgery?
Health-related quality-of-life (HRQOL) measures are being used more frequently in the evaluation of the adult deformity patient. This is due in part to the validation of the deformity-specific Scolios Research Society-22 (SRS-22). Hence, relationships between HRQOL outcomes and traditional measures of success such as deformity correction, fusion healing, and complications are being established. ⋯ This study supports the application of HRQOL measures, including the deformity-specific SRS-22, as a valuable tool in the assessment of adult deformity patients. Change in outcome score stabilized after the 1-year postoperative interval, for most patients.