PROximal Fracture of the Humerus: Evaluation by Randomisation trial no. 2 (PROFHER-2 trial): a three-arm randomised controlled trial to assess the effectiveness and cost-effectiveness of reverse shoulder arthroplasty versus hemiarthroplasty versus non-surgical care for acute three and four-part fractures of the proximal humerus in patients over 65 years of age

South Tees Hospitals NHS Foundation Trust0 个研究点目标入组 359 人开始时间: 2018年4月5日最近更新: 2024年6月10日

适应症

试验速览

暂无简介。

•1. Adult patients aged 65 years or over
•2. Radiographically confirmed acute three-part (including surgical neck) or four-part displaced fracture of the proximal humerus (Neer Classification) including head-splitting fractures of the humeral head and fracture dislocations
•3. Trial interventions can be provided within 5 weeks of injury
•4. Patient is deemed by the clinical care team to be fit for surgery
•5. Able to provide full informed consent

•1. Patients who are unable to adhere to trial procedures or complete questionnaires
•2. Polytrauma – where one or more additional fractures, which may affect the outcome measures for the trial, are present or other body-systems are affected
•3. Open fractures or fractures where there is severe soft tissue compromise requiring urgent surgery
•4. Pathological (other than osteoporotic) fractures
•5. Presence of axillary nerve palsy (given that this results in a weakening of the deltoid muscle, upon which the shoulder relies for function)

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