Spine
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Randomized Controlled Trial Multicenter Study
Evaluation of surgical volume and the early experience with lumbar total disc replacement as part of the investigational device exemption study of the Charité Artificial Disc.
A prospective, randomized, multicenter, Food and Drug Administration regulated Investigational Device Exemption (IDE) clinical trial. ⋯ Surgeons and institutions with a high volume of lumbar total disc replacement cases have a reduction in key perioperative and postoperative parameters that provide a clinical and/or economic benefit. Surgeons may expect longer hospital stays, higher blood loss, and a higher rate of certain complications in their early experience with total disc replacement procedures, but there was no effect on clinical outcomes.
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Multicenter Study Comparative Study
Comparison of the lowest instrumented, stable, and lower end vertebrae in "single overhang" thoracic adolescent idiopathic scoliosis: anterior versus posterior spinal fusion.
A retrospective multicenter study. ⋯ These data confirm that anterior spinal fusion techniques result in a mean shorter fusion of 1.5 vertebral segments/patient when compared to posterior spinal fusion techniques with respect to the position of the lowest instrumented and stable vertebrae for "single overhang" thoracic (Lenke 1A/B) curves. However, because this is a retrospective multicenter study over 10 years, it represents various posterior spinal fusion techniques that do not include all pedicle screw constructs.
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Multicenter Study Clinical Trial
Balloon kyphoplasty for symptomatic vertebral body compression fractures results in rapid, significant, and sustained improvements in back pain, function, and quality of life for elderly patients.
Prospective, single-arm interventional cohort. ⋯ Elderly patients with symptomatic VCFs had rapid, significant, and sustained improvements in back pain, back function, and quality of life following balloon kyphoplasty.
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Multicenter, prospective, consecutive clinical series. ⋯ A clinical impact classification has been established based on radiographic markers of disability. The classification has shown correlation with self-reported disability as well as rates of operative treatment.
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Randomized Controlled Trial Multicenter Study
Cost-utility analysis of physiotherapy treatment compared with physiotherapy advice in low back pain.
Economic evaluation alongside a pragmatic multicenter randomized controlled trial from the National Health Service (NHS) and societal perspective. ⋯ The results indicate no significant differences in either NHS costs or effects. However, the significantly higher out-of-pocket expenses incurred by patients receiving routine physiotherapy suggests that advice given by a physiotherapist should be considered as the first-line treatment for patients with this level of back pain disability.