Journal of neurosurgery. Spine
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Randomized Controlled Trial Multicenter Study Comparative Study
A 5- to 8-year randomized study on the treatment of cervical radiculopathy: anterior cervical decompression and fusion plus physiotherapy versus physiotherapy alone.
OBJECTIVE The aim of this study was to evaluate the 5- to 8-year outcome of anterior cervical decompression and fusion (ACDF) combined with a structured physiotherapy program as compared with that following the same physiotherapy program alone in patients with cervical radiculopathy. No previous prospective randomized studies with a follow-up of more than 2 years have compared outcomes of surgical versus nonsurgical intervention for cervical radiculopathy. METHODS Fifty-nine patients were randomized to ACDF surgery with postoperative physiotherapy (30 patients) or to structured physiotherapy alone (29 patients). ⋯ CONCLUSIONS In this prospective randomized study of 5- to 8-year outcomes of surgical versus nonsurgical treatment in patients with cervical radiculopathy, ACDF combined with physiotherapy reduced neck disability and neck pain more effectively than physiotherapy alone. Self-rating by patients as regards treatment outcome was also superior in the surgery group. No significant differences were seen between the 2 patient groups as regards arm pain and health outcome.
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Randomized Controlled Trial Multicenter Study Comparative Study
Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial.
OBJECTIVE The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF). Although the long-term outcome of single-level disc replacement has been extensively described, there have not been previous reports of the 5-year outcome of 2-level cervical disc replacement. METHODS This study reports the 5-year results of a prospective, randomized US FDA investigational device exemption (IDE) study conducted at 24 centers in patients with 2-level, contiguous, cervical spondylosis. ⋯ However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus ACDF control patients. Clinical trial registration no. NCT00389597 ( clinicaltrials.gov ).
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Randomized Controlled Trial
Seven-year cost-effectiveness of ProDisc-C total disc replacement: results from investigational device exemption and post-approval studies.
OBJECTIVE The purpose of this study was to evaluate the 7-year cost-effectiveness of cervical total disc replacement (CTDR) versus anterior cervical discectomy and fusion (ACDF) for the treatment of patients with single-level symptomatic degenerative disc disease. A change in the spending trajectory for spine care is to be achieved, in part, through the selection of interventions that have been proven effective yet cost less than other options. This analysis complements and builds upon findings from other cost-effectiveness evaluations of CTDR through the use of long-term, patient-level data from a randomized study. ⋯ CTDR was cost-effective in 99.8% of sensitivity analysis simulations and generated a mean incremental NMB of $20,679 (95% CI $6053-$35,377) per patient at a willingness-to-pay threshold of $50,000/QALY. CONCLUSIONS Based on this modeling evaluation, CTDR was found to be more effective and less costly over a 7-year time horizon for patients with single-level symptomatic degenerative disc disease. These results are robust across a range of scenarios and perspectives and are intended to support value-based decision making.
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Randomized Controlled Trial
Postoperative posterior lumbar muscle changes and their relationship to segmental motion preservation or restriction: a randomized prospective study.
To date, it remains unclear whether the preservation of segmental motion by total disc replacement (TDR) or motion restriction by stand-alone anterior lumbar interbody fusion (ALIF) have an influence on postoperative degeneration of the posterior paraspinal muscles or the associated clinical results. Therefore, the purpose of the present prospective randomized study was to evaluate the clinical parameters and 3D quantitative radiological changes in the paraspinal muscles of the lumbar spine in surgically treated segments and superior adjacent segments after ALIF and TDR. ⋯ Motion restriction via stand-alone ALIF and motion preservation via TDR both present small changes in the posterior lumbar paraspinal muscles with regard to volume atrophy or fatty degeneration at the index and superior adjacent segments. Therefore, although the clinical outcome was not affected by the observed muscular changes, the authors concluded that the expected negative influence of motion restriction on the posterior muscles compared with motion preservation does not occur on a clinically relevant level.