European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
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The randomized controlled trial (RCT) is generally accepted as the most reliable method of conducting clinical research. To obtain an unbiased evaluation of the effectiveness of spine surgery, patients should be randomly assigned to either new or standard treatment. The aim of the present article is to provide a short overview of the advantages and challenges of RCTs and to present a summary of the conclusions of the Cochrane Reviews in spine surgery and later published trials in order to evaluate their contribution to quality management and feasibility in practice. ⋯ The only intervention that receives strong evidence is discectomy for faster relief in carefully selected patients due to lumbar disc prolapse with sciatica. For future trials, authors, referees, and editors are recommended to follow the CONSORT statement. RCTs provide evidence to support clinical opinions before implementation of new techniques, but the individual clinical experience is still important for the doctor who has to face the patient.
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Studies comparing the relative merits of microdiscectomy and standard discectomy report conflicting results, depending on the outcome measure of interest. Most trials are small, and few have employed validated, multidimensional patient-orientated outcome measures, considered essential in outcomes research. In the present study, data were collected prospectively from six surgeons participating in a surgical registry. ⋯ Though not equivalent to an RCT, the study included every single eligible patient in our Spine Center and allowed surgeons to use their regular procedure; it hence had extremely high external validity (relevance/generalisability). There was no clinically relevant difference in outcome after lumbar disc excision dependent on the use of the microscope. The decision to use the microscope should rest with the surgeon.
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Randomized Controlled Trial
Perioperative and short-term advantages of mini-open approach for lumbar spinal fusion.
It has been widely reported a vascular and neurologic damage of the lumbar muscles produced in the classic posterior approach for lumbar spinal fusions. The purpose of this study is to demonstrate a better clinical and functional outcome in the postoperative and short term in patients undergoing minimal invasive surgery ("mini-open") for this lumbar spinal arthrodesis. We designed a prospective study with a 30 individuals cohort randomized in two groups, depending on the approach performed to get a instrumented lumbar circumferential arthrodesis: "classic posterior" (CL group) or "mini-open" approach (MO group). ⋯ No significant differences were found between two groups in surgery timing, X-rays exposure or sciatic postoperative pain. This study, inline with previous investigations, reinforces the concept of minimizing the muscular lumbar damage with a mini-open approach for a faster and better recovery of patients' disability in the short term. Further investigations are necessary to confirm these findings in the long term, and to verify the achievement of a stable lumbar spinal fusion.