Spine
-
Randomized Controlled Trial Multicenter Study Clinical Trial
Cost-effectiveness of lumbar fusion and nonsurgical treatment for chronic low back pain in the Swedish Lumbar Spine Study: a multicenter, randomized, controlled trial from the Swedish Lumbar Spine Study Group.
A cost-effectiveness study was performed from the societal and health care perspectives. ⋯ For both the society and the health care sectors, the 2-year costs for lumbar fusion was significantly higher compared with nonsurgical treatment but all treatment effects were significantly in favor of surgery. The probability of lumbar fusion being cost-effective increased with the value put on extra effect units gained by using surgery.
-
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A prospective, randomized controlled clinical trial of anterior lumbar interbody fusion using a titanium cylindrical threaded fusion device.
A prospective, randomized, controlled clinical trial comparing a cylindrical threaded titanium cage to a femoral ring allograft control for anterior lumbar interbody fusion. ⋯ Cylindrical threaded titanium cages have a higher fusion rate, comparable improvements in clinical outcome (Oswestry, Low Back Pain Questionnaire, SF-36), and fewer secondary supplemental fixation procedures compared to the femoral ring allograft control.
-
Multicenter Study Clinical Trial
Intermediate follow-up after treatment of degenerative disc disease with the Bryan Cervical Disc Prosthesis: single-level and bi-level.
Prospective, concurrently enrolled, multicenter trials of the Bryan Cervical Disc Prosthesis (Medtronic Sofamor Danek, Memphis, TN) were conducted for the treatment of patients with single-level and two-level (bi-level) degenerative disc disease of the cervical spine. ⋯ Clinical success for both studies exceeded the study acceptance criteria of 85%. At 1-year follow-up, the flexion-extension range of motion per level: Discectomy and implantation of the device alleviates neurologic symptoms and signs similar to anterior cervical discectomy and fusion. Radiographic evidence supports maintenance of motion. The procedure is safe and the patients recover quickly. At least 5 years of follow-up will be needed to assess the long-term functionality of the prosthesis and protective influence on adjacent levels.
-
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.