4 results match your criteria: "and Texas Back Institute Research Foundation[Affiliation]"

Comparison of 2 lumbar total disc replacements: results of a prospective, randomized, controlled, multicenter Food and Drug Administration trial with 24-month follow-up.

Spine (Phila Pa 1976)

May 2014

*Texas Back Institute, Plano, TX †Loveland Orthopedic Clinic, Loveland, CO ‡Orthopedics International, Kirkland, WA §Triangle Orthopaedic Associates, Durham, NC ¶Carolina Neurosurgery and Spine Associates, Charlotte, NC ‖Towson Orthopaedic Associates, Scoliosis and Spine Center, Towson, MD; and **Texas Back Institute Research Foundation, Plano, TX.

Study Design: This was a prospective, randomized, controlled multicenter study with 24-month follow-up.

Objective: The purpose of this study was to evaluate the safety and efficacy in a Food and Drug Administration Investigation Device Exemption of a new lumbar total disc replacement (TDR) by comparing it to an earlier TDR approved for sale.

Summary Of Background Data: Randomized trials have reported TDR to produce results similar or superior to lumbar fusion.

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Background Context: Avascular necrosis is a commonly described condition caused by a disruption of blood supply to the bones, resulting in necrosis. Although common in joints of the extremities, it is seen less often in the spine. Risk factors for avascular necrosis include steroid use, alcohol consumption, smoking, scuba diving, thrombosis, hypercoagulability, and hypertension.

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This study represents the first 39 patients with at least 6-month follow-up enrolled in a prospective randomized Food and Drug Administration study evaluating the safety and efficacy of the ProDisc II versus the control, a 360 degrees lumbar spinal fusion. Data were collected preoperatively and at 6 weeks, 3 months, and 6 months postoperatively. Visual Analog Scale (VAS), Oswestry Low Back Pain Disability Questionnaire (ODQ), and patient satisfaction rates were evaluated at these intervals, as well as range of motion, return to work, and recreational and ambulatory status.

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Objective: The purpose of this study was to determine if vibration pain provocation could be combined with magnetic resonance imaging (MRI) to increase its specificity in identifying symptomatic disc disruption identified by discography.

Design: Prospective single-blind study.

Setting: Data were collected at a spine specialty clinic and at a diagnostic imaging center.

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