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首页> 外文OA文献 >Cast versus functional brace in the rehabilitation of patients treated non-operatively for a rupture of the Achilles tendon: protocol for the UK study of tendo achilles rehabilitation (UK STAR) multi-centre randomised trial
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Cast versus functional brace in the rehabilitation of patients treated non-operatively for a rupture of the Achilles tendon: protocol for the UK study of tendo achilles rehabilitation (UK STAR) multi-centre randomised trial

机译：因脚跟腱断裂而接受非手术治疗的患者在康复中使用石膏支架或功能性支架：英国腱跟跟康复研究协议（UK STAR）多中心随机试验

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Achilles tendon rupture affects over 11 000 people yearly in the UK, and the incidence is increasing. Controversy remains with regard to the best rehabilitation strategy for these patients. In operatively treated patients, functional bracing provides better outcomes compared with plaster casts. However, the role of functional bracing in non-operatively managed patients is unclear. This is the protocol for a multicentre randomised trial of plaster cast immobilisation versus functional bracing for patients with a non-operatively managed Achilles tendon rupture.All adults presenting with a primary rupture of the Achilles tendon will be screened. Non-operatively treated patients will be eligible to take part in the trial. Broad eligibility criteria will ensure that the results of the study can be generalised to the wider patient population. Randomisation will be on a 1:1 basis. Both rehabilitation strategies are widely used within the National Health Service. Standardised protocols will be followed, and details of plaster material and brace will be as per the site's usual practice.A minimum of 330 patients will be randomised to obtain 90% power to detect a difference of 8 points in Achilles Tendon Total Rupture Score at 9 months. Quality of life and resource use will be collected at 3, 6 and 9 months. The differences between treatment groups will be assessed on an intention-to-treat basis. The results of the trial-based economic evaluation will be expressed in terms of incremental cost per quality-adjusted life-year gained.The National Research Ethic Committee approved this study on 18 March 2016 (16/SC/0109).The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of the trial (summer 2019). The results of this trial will substantially inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury. This study has been registered on the International Standard Randomised Controlled Trial Number registry with reference no ISRCTN62639639.
机译：跟腱断裂在英国每年影响超过11000人，并且发病率正在增加。对于这些患者的最佳康复策略仍存在争议。在接受手术治疗的患者中，功能支撑比石膏石膏提供更好的结果。但是，尚不清楚功能性支撑在非手术治疗患者中的作用。这是针对非手术性跟腱断裂的患者进行石膏石膏固定与功能性支具固定性多中心随机试验的方案，将对所有出现跟腱初次断裂的成年人进行筛查。未经手术治疗的患者将有资格参加试验。广泛的资格标准将确保研究结果可以推广到更广泛的患者群体。随机化将以1：1为基础。两种康复策略均在国家卫生局内广泛使用。将遵循标准化协议，并按照现场惯例使用石膏材料和支架的详细信息。至少330名患者将被随机分配以获得90％的能力，以检测9分的跟腱腱断裂总分8分个月。将在3、6和9个月时收集生活质量和资源使用情况。治疗组之间的差异将以意向治疗为基础进行评估。基于试验的经济评估的结果将以每质量调整生命年增加的成本表示。国家研究伦理委员会于2016年3月18日批准了这项研究（16 / SC / 0109）。该研究完成后（2019年夏季），将提交《健康研究健康技术评估》专着和同行评审期刊的手稿。该试验的结果将极大地指导临床实践，以治疗这种损伤的临床和成本效益。该研究已在国际标准随机对照试验编号注册中心进行了注册，引用号为ISRCTN62639639。

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