Achten Juul, Parsons Nick R, Kearney Rebecca L, Maia Schlüssel Michael, Liew Anna S, Dutton Susan, Petrou Stavros, Ollivere Benjamin, Lamb Sarah E, Costa Matthew L
Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Statistics and Epidemiology Unit, Warwick Medical School, University of Warwick, Coventry, UK.
BMJ Open. 2017 Oct 24;7(10):e019628. doi: 10.1136/bmjopen-2017-019628.
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.
在英国，每年有超过11000人发生跟腱断裂，且发病率呈上升趋势。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，功能性支具比石膏固定效果更好。然而，功能性支具在非手术治疗患者中的作用尚不清楚。这是一项多中心随机试验的方案，旨在比较石膏固定与功能性支具对非手术治疗的跟腱断裂患者的疗效。
将对所有出现原发性跟腱断裂的成年人进行筛查。非手术治疗的患者将有资格参加该试验。广泛的纳入标准将确保研究结果能够推广到更广泛的患者群体。随机分组将按1:1进行。两种康复策略在英国国家医疗服务体系中都被广泛使用。将遵循标准化方案，石膏材料和支具的细节将按照各研究地点的常规做法。至少330名患者将被随机分组，以获得90%的检验效能，检测9个月时跟腱完全断裂评分相差8分的差异。将在3个月、6个月和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在意向性分析的基础上进行评估。基于试验的经济评估结果将以每获得一个质量调整生命年的增量成本来表示。
国家研究伦理委员会于2016年3月18日批准了本研究（16/SC/0109）。试验完成后（2019年夏季），将向英国国家卫生研究院健康技术评估专著以及同行评审期刊提交一份手稿。本试验的结果将为该损伤治疗的临床实践和成本效益提供重要信息。本研究已在国际标准随机对照试验编号注册中心注册，注册号为ISRCTN62639639。
