Bmc Musculoskel Dis
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Bmc Musculoskel Dis · Oct 2016
Randomized Controlled Trial Multicenter Study Comparative StudyA protocol of a randomized controlled multicenter trial for surgical treatment of lumbar spondylolisthesis: the Lumbar Interbody Fusion Trial (LIFT).
With a steep increase in the number of instrumented spinal fusion procedures, there is a need for comparative data to develop evidence based treatment recommendations. Currently, the available data on cost and clinical effectiveness of the two most frequently performed surgeries for lumbar spondylolisthesis, transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF), are not sufficient. Therefore, current guidelines do not advise which is the most appropriate surgical treatment strategy for these patients. Non-randomized studies comparing TLIF and PLIF moreover suggest that TLIF is associated with fewer complications, less blood loss, shorter surgical time and hospital duration. TLIF may therefore be more cost-effective. The results of this study will provide knowledge on short- and long-term clinical and economical effects of TLIF and PLIF procedures, which will lead to recommendations for treating patients with lumbar spondylolisthesis. ⋯ It is hypothesized that TLIF, compared to PLIF, has similar clinical outcome or is possibly better in reducing disability. Moreover, direct medical costs are expected to be lower due to less surgical morbidity, shorter hospital stay and shorter surgical time. Indirect costs are assumed to be lower for TLIF as well, because we suspect less working days are lost. Currently, prospective data comparing clinical and cost-effectiveness of both techniques are not available. Therefore, in clinical practice both techniques are used and the choice for technique is greatly based on surgeon's preference. The demand for spinal fusion surgery has risen steeply over the last 10 years and is expected to increase even further in the near future. As a result, the burden on society (and the working population) will increase. In case our hypothesis is confirmed, treatment guidelines will be adapted, and TLIF will be recommended as first choice surgical treatment of lumbar spondylolisthesis. Ultimately this will lead to reduction of (direct and indirect) costs and better clinical outcome for spondylolisthesis patients eligible for instrumented spinal surgery.
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Bmc Musculoskel Dis · Oct 2016
Randomized Controlled Trial Multicenter Study Comparative StudyThe clinical and cost effectiveness of steroid injection compared with night splints for carpal tunnel syndrome: the INSTINCTS randomised clinical trial study protocol.
Patients diagnosed with idiopathic mild to moderate carpal tunnel syndrome (CTS) are usually managed in primary care and commonly treated with night splints and/or corticosteroid injection. The comparative effectiveness of these interventions has not been reliably established nor investigated in the medium and long term. The primary objective of this trial is to investigate whether corticosteroid injection is effective in reducing symptoms and improving hand function in mild to moderate CTS over 6 weeks when compared with night splints. Secondary objectives are to determine specified comparative clinical outcomes and cost effectiveness of corticosteroid injection over 6 and 24 months. ⋯ The trial makes an important contribution to the evidence base available to support effective conservative management of CTS in primary care. No previous trials have directly compared these treatments for CTS in primary care populations, reported on clinical effectiveness at more than 6 months nor compared cost effectiveness of the interventions.
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Bmc Musculoskel Dis · Sep 2016
Randomized Controlled Trial Comparative StudyCemented compared to uncemented femoral stems in total hip replacement for displaced femoral neck fractures in the elderly: study protocol for a single-blinded, randomized controlled trial (CHANCE-trial).
Total hip replacement (THR) is the preferred method for the active and lucid elderly patient with a displaced femoral neck fracture (FNF). But controversy still exists regarding using cemented or uncemented stem in these patients. The aim of this study is to compare a cemented and uncemented femoral stem in patients 65-79 years treated surgically with THR for displaced FNF. ⋯ The ethical committee at Karolinska Institutet has approved the study. An interim analysis on the primary endpoints will be performed when half the sample size is included. The results from the study will be disseminated to the medical community via presentations and publications in relevant medical journals. The study will provide evidence if a cemented or uncemented femoral stem is preferable in THR for elderly patients with a displaced FNF.
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Bmc Musculoskel Dis · Aug 2016
Randomized Controlled Trial Multicenter Study Comparative StudyLong head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol.
Optimal treatment of the diseased long head of the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or tenodesis. A recent meta analysis revealed no difference in strength or functional outcome between treatments. The included studies varied in methodological quality, and only two were randomized controlled trials (RCTs). As strong evidence in favor of either tenotomy or tenodesis is still lacking, we designed this randomized controlled trial to compare functional outcomes after tenotomy and tenodesis when performed in adjunct to arthroscopic rotator cuff repair. ⋯ Treatment of LHB tendon lesions is performed differently around the world and meta analyses do not provide conclusive evidence in favor of one of these treatments. This study will strengthen evidence on the risks and benefits of LHB tenotomy and tenodesis in adjunct to a rotator cuff repair, which is important for managing patient expectations.
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Bmc Musculoskel Dis · Aug 2016
Randomized Controlled Trial Comparative Study Observational StudyEvaluation of a risk-stratification strategy to improve primary care for low back pain: the MATCH cluster randomized trial protocol.
Despite numerous options for treating back pain and the increasing healthcare resources devoted to this problem, the prevalence and impact of back pain-related disability has not improved. It is now recognized that psychosocial factors, as well as physical factors, are important predictors of poor outcomes for back pain. A promising new approach that matches treatments to the physical and psychosocial obstacles to recovery, the STarT Back risk stratification approach, improved patients' physical function while reducing costs of care in the United Kingdom (UK). This trial evaluates implementation of this strategy in a United States (US) healthcare setting. ⋯ This trial will provide the first randomized trial evidence of the clinical effectiveness of implementing risk stratification with matched treatment options for low back pain in a United States health care delivery system.