Comparison of Volar-flexion, Ulnar-deviation and Functional Position Cast Immobilization in the Non-operative Treatment of Distal Radius Fracture in Elderly Patients: a Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 3
- 主要终点
- Patient Rated Wrist Evaluation (PRWE) measure is the primary outcome measure of wrist pain and disability in the study
研究概览
简要总结
There is no consensus about the best conservative treatment for patients with dorsally displaced distal radius fractures. The previous studies that have examined the most valid method for cast immobilization have lacked uniform and patient-rated outcome measures, proper randomization and sufficient study population. The aim of this study is to compare functional position cast to flexion-ulnar -deviation with dorsally displaced distal radius fractures in patients aged 65 years or older. The conservative treatment is performed in clinical practice by various health care professionals with different techniques of reduction which are not limited to any specific technique in this pragmatic, randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low energy intra- or extra-articular dorsal primarily stable, reducible DRF within 3 cm of the radiocarpal joint diagnosed with lateral and posterior-anterior radiographs in ER
- •Physician on-call (general practitioner, acute physician, orthopedic resident, orthopedic consult) thinks patient could be appropriate for non-operative treatment
排除标准
- •Operative treatment
- •Refuse to participate the study
- •Open fracture more than Gustilo 1 gradus
- •Age under 65 years
- •Chauffeure's or Barton´s fracture
- •Smith´s fracture (volar angulation of the fracture)
- •Does not understand written and spoken guidance in local languages
- •Pathological fracture or previous fracture in the same wrist, forearm or elbow
研究组 & 干预措施
Arm 1
Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.
干预措施: Flexion-ulnar cast (Other)
Arm 2
Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.
干预措施: Functional cast (Other)
结局指标
主要结局
Patient Rated Wrist Evaluation (PRWE) measure is the primary outcome measure of wrist pain and disability in the study
时间窗: 2 years
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists three subscales: Pain, Function and Cosmetics.
次要结局
- Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire.(2 years)
- Pain measured in Visual Analogue Scale (VAS).(Baseline, 3 months, 1 year, 2 years)
- Grip strength is measured with a dynamometer(3 months)
- The pain catastrophizing scale (PCS) is measured with a self-administered questionnaire.(2 years)
- Quality of life measured with the 15-D.(2 years)
- Range of motion (ROM) is measured with a goniometer(3 months)
研究者
Teemu Hevonkorpi
MBBS
Tampere University Hospital