The spine journal : official journal of the North American Spine Society
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Multicenter Study Clinical Trial
Effectiveness of a low back pain classification system.
One goal of low back pain (LBP) assessment is to direct clinicians to specific subgroups that benefit from particular treatment approaches. ⋯ LBP is a heterogeneous condition and treatment results may significantly improve when clinically relevant syndromes are determined initially to guide treatment. Classifying LBP based on pattern recognition shows promise to help clarify future clinical trials and surgical referrals.
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Randomized Controlled Trial Multicenter Study
Effect of intervertebral disc height on postoperative motion and clinical outcomes after Prodisc-C cervical disc replacement.
Cervical total disc replacement (TDR) is an emerging technology. However, the factors that influence postoperative range of motion (ROM) and patient satisfaction are not fully understood. ⋯ Patients with greater disc collapse of less than 4mm preoperative disc height benefit more in ROM after TDR. The optimal postoperative disc height range to maximize ROM is between 5 and 7mm. This optimal range did not translate into better clinical outcome at 2-year follow-up.
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Randomized Controlled Trial Multicenter Study
Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: five-year follow-up.
The CHARITE artificial disc, a lumbar spinal arthroplasty device, was approved by the United States Food and Drug Administration in 2004 based on two-year safety and effectiveness data from a multicenter, prospective, randomized investigational device exemption (IDE) study. No long-term, randomized, prospective study on the CHARITE disc or any other artificial disc has been published to date. ⋯ The results of this five-year, prospective, randomized multicenter study are consistent with the two-year reports of noninferiority of CHARITE artificial disc vs. ALIF with BAK and iliac crest autograft. No statistical differences were found in clinical outcomes between groups. In addition, CHARITE patients reached a statistically greater rate of part- and full-time employment and a statistically lower rate of long-term disability, compared with BAK patients. Radiographically, the ROMs at index- and adjacent levels were not statistically different from those observed at two-years postsurgery.
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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.