Bmc Musculoskel Dis
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Bmc Musculoskel Dis · Jan 2010
Randomized Controlled Trial Multicenter StudyThe NEtherlands Cervical Kinematics (NECK) trial. Cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blind randomised multicenter study.
Patients with cervical radicular syndrome due to disc herniation refractory to conservative treatment are offered surgical treatment. Anterior cervical discectomy is the standard procedure, often in combination with interbody fusion. Accelerated adjacent disc degeneration is a known entity on the long term. Recently, cervical disc prostheses are developed to maintain motion and possibly reduce the incidence of adjacent disc degeneration. A comparative cost-effectiveness study focused on adjacent segment degeneration and functional outcome has not been performed yet. We present the design of the NECK trial, a randomised study on cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in patients with cervical disc herniation. ⋯ Currently, anterior cervical discectomy with fusion is the golden standard in the surgical treatment of cervical disc herniation. Whether additional interbody fusion or disc prosthesis is necessary and cost-effective will be determined by this trial.
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Bmc Musculoskel Dis · Jan 2010
Randomized Controlled Trial Multicenter Study Comparative StudyPrimary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly (ProCon): a multicenter randomized controlled trial.
Fractures of the proximal humerus are associated with a profound temporary and sometimes permanent, impairment of function and quality of life. The treatment of comminuted fractures of the proximal humerus like selected three-or four-part fractures and split fractures of the humeral head is a demanding and unresolved problem, especially in the elderly. Locking plates appear to offer improved fixation; however, screw cut-out rates ranges due to fracture collapse are high. As this may lead to higher rates of revision surgery, it may be preferable to treat comminuted fractures in the elderly primarily with a prosthesis or non-operatively. Results from case series and a small-sample randomized controlled trial (RCT) suggest improved function and less pain after primary hemiarthroplasty (HA); however these studies had some limitations and a RCT is needed. The primary aim of this study is to compare the Constant scores (reflecting functional outcome and pain) at one year after primary HA versus non-operative treatment in elderly patients who sustained a comminuted proximal humeral fracture. Secondary aims include effects on functional outcome, pain, complications, quality of life, and cost-effectiveness. ⋯ This trial will provide level-1 evidence on the effectiveness of the two mostly applied treatment options for three-or four part and split head proximal humeral fractures in the elderly. These data may support the development of a clinical guideline for treatment of these traumatic injuries.
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Bmc Musculoskel Dis · Jan 2010
Randomized Controlled Trial Multicenter StudyThe Felix-trial. Double-blind randomization of interspinous implant or bony decompression for treatment of spinal stenosis related intermittent neurogenic claudication.
Decompressive laminotomy is the standard surgical procedure in the treatment of patients with canal stenosis related intermittent neurogenic claudication. New techniques, such as interspinous process implants, claim a shorter hospital stay, less post-operative pain and equal long-term functional outcome. A comparative (cost-) effectiveness study has not been performed yet. This protocol describes the design of a randomized controlled trial (RCT) on (cost-) effectiveness of the use of interspinous process implants versus conventional decompression surgery in patients with lumbar spinal stenosis. ⋯ Currently decompressive laminotomy is the golden standard in the surgical treatment of lumbar spinal stenosis. Whether surgery with interspinous implants is a reasonable alternative can be determined by this trial.
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Bmc Musculoskel Dis · Jan 2010
Randomized Controlled Trial Multicenter StudyFluid lavage of open wounds (FLOW): design and rationale for a large, multicenter collaborative 2 x 3 factorial trial of irrigating pressures and solutions in patients with open fractures.
Open fractures frequently result in serious complications for patients, including infections, wound healing problems, and failure of fracture healing, many of which necessitate subsequent operations. One of the most important steps in the initial management of open fractures is a thorough wound irrigation and debridement to remove any contaminants. There is, however, currently no consensus regarding the optimal approach to irrigating open fracture wounds during the initial operative procedure. The selection of both the type of irrigating fluid and the pressure of fluid delivery remain controversial. The primary objective of this study is to investigate the effects of irrigation solutions (soap vs. normal saline) and pressure (low vs. high; gravity flow vs. high; low vs. gravity flow) on re-operation within one year among patients with open fractures. ⋯ This study represents a major international effort to identify a simple and easily applicable strategy for emergency wound management. The importance of the question and the potential to identify a low cost treatment strategy argues strongly for global participation, especially in low and middle income countries such as India and China where disability from traumatic injuries is substantial.
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Bmc Musculoskel Dis · Jan 2010
Randomized Controlled Trial Comparative StudyIMPaCT Back study protocol. Implementation of subgrouping for targeted treatment systems for low back pain patients in primary care: a prospective population-based sequential comparison.
Prognostic assessment tools to identify subgroups of patients at risk of persistent low back pain who may benefit from targeted treatments have been developed and validated in primary care. The IMPaCT Back study is investigating the effects of introducing and supporting a subgrouping for targeted treatment system in primary care. ⋯ International Standard Randomised Controlled Trial Number Register ISRCTN55174281.