Spine
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
ProDisc artificial total lumbar disc replacement: introduction and early results from the United States clinical trial.
Multicenter prospective randomized study of artificial disc replacement (ProDisc) versus circumferential fusion (standard of care) for one- and two-level degenerative disc disease. This is an interim analysis on patients seen at the Spine Institute Saint John's Health Center, Santa Monica, California. ⋯ Disc replacement patients reported significantly less pain (Visual Analogue Scale) and disability (Oswestry) in the early period following surgery compared to fusion patients. This difference disappeared by 6 months. When compared to fusion, the disc replacement allowed preservation of motion at L4-L5 with a similar trend at L5-S1.
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Randomized Controlled Trial Comparative Study Clinical Trial
Does early intervention with a light mobilization program reduce long-term sick leave for low back pain: a 3-year follow-up study.
A randomized clinical trial. ⋯ For patients with subacute low back pain, a brief and simple early intervention with examination, information, reassurance, and encouragement to engage in physical activity as normal as possible had economic gains for the society. The effect occurred during the first year after intervention. There were no significant long-term effects of the intervention. The initial gain obtained during the first year does not lead to any increased costs or increased risks for reoccurrence of illness over the next 2 years.
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Randomized Controlled Trial Comparative Study Clinical Trial
Clinical results with ProDisc: European experience and U.S. investigation device exemption study.
This study is based on a review of the literature related to the use of the ProDisc device and a report of the preliminary results of a prospective randomized study. ⋯ The preliminary results of this prospective randomized study found that peri-operative factors were more favorable in the disc replacement group than in the fusion group. There was a trend to greater patient satisfaction in this group. These early results suggest that total disc replacement may be a viable alternative to lumbar spinal fusion in patients with symptomatic disc disruption unresponsive to nonoperative care. Long-term follow-up is needed and is currently being collected for this study group.
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Clinical Trial
The feasibility, safety, and utility of vertebral wedge osteotomies for the fusionless treatment of paralytic scoliosis.
Before-after intervention study of a fusionless surgical technique to correct scoliosis secondary to spinal cord injury or myelodysplasia in children and adolescents. ⋯ The vertebral wedge osteotomy procedure appears to be a potential option for the treatment of paralytic scoliosis. The procedure was feasible and safely performed in these 14 patients, with spinal mobility maintained. There were no nonunions. The efficacy of the procedure is still not known, as is for which patients the procedure is indicated and timing of the operation. Long-term follow-up (to skeletal maturity) is needed. Only six of the patients are currently skeletally mature, and more numbers are needed to determine efficacy in this group.
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Comparative Study
Factors involved in the decision to perform a selective versus nonselective fusion of Lenke 1B and 1C (King-Moe II) curves in adolescent idiopathic scoliosis.
A retrospective evaluation of 203 adolescent idiopathic scoliosis patients with Lenke 1B or 1C (King-Moe II) type curves. ⋯ The characteristics of the compensatory "nonstructural" lumbar curve played a significant role in the surgical decision-making process and varied substantially among members of the study group. Side-bending correction of the lumbar curve to <25 degrees (defining these as Lenke 1, nonstructural lumbar curves) was not sufficientcriteria to perform a selective fusion in some of these cases. The substantial variation in the frequency of fusing the lumbar curve (6% to 33%) confirms that controversy remains about when surgeons feel the lumbar curve can be spared in Lenke 1B and 1C curves. Site-specific analysis revealed that the radiographic features significantly associated with a selective fusion varied according to the site at which the patient was treated. The rate of selective fusion was 92% for the 1B type curves compared to 68% for the 1C curves.