Non- or Minimally Displaced Distal Radius Fractures in Adult Patients <50 Years of Age Treated Non-operatively: Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation a Multicenter Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 试验地点
- 6
- 主要终点
- Patient Related Wrist Evaluation
研究概览
简要总结
Three weeks of cast immobilisation versus one week of brace immobilisation in non- or minimally displaced distal radius fractures in adult patients <50 years of age treated non-operatively.
详细描述
Background: Currently, non- or minimally displaced distal radius fractures are treated by three to five weeks of cast immobilisation. Many patients with a distal radius fracture suffer from long-term functional restrictions, which might be related to stiffness due to cast immobilisation. Current literature indicates that one week of immobilisation might be safe, however, no level one evidence is available. This trial aims to compare one week of brace immobilisation with three weeks of cast immobilisation in patients with distal radius fractures that do not need reduction.
Methods: The aim of this trial is to evaluate the non-inferiority of one week of brace immobilisation in patients with non- or minimally displaced distal radius fractures. A single blinded multicentre randomised clinical trial will be conducted in three hospitals. Adult patients, between 18-50 years old, independent for activities of daily living, with a non- or minimally displaced distal radius fracture can be included in this study. The intervention group is treated with one week of brace immobilisation, and the control group with three weeks of cast immobilisation. Primary outcome is the Patient-Related Wrist Evaluation-score at six months. Secondary outcomes are: Quick Disabilities of the Arm, Shoulder and Hand-score at six weeks and six months, PRWE at six weeks, range of motion, pain, radiological outcome, complications and cost effectiveness measured by the EuroQol 5 Dimension questionnaire, Medical Consumption Questionnaire and Productivity Cost Questionnaire.
Discussion: This study will provide evidence on the optimal period of immobilisation in non-operatively treated displaced and reduced distal radius fractures. Both treatment options are accepted treatment protocols and both treatment options have a low risk of complications. Follow-up will be according to the current treatment protocol. This study will provide level one evidence on the optimal period and way of immobilisation for non- or minimally displaced distal radius fractures in adult patients.
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
- Single (Outcomes Assessor)
盲法说明
A blinded evaluation of the trial patients functional status, radiographs and range of motion will be performed by a research assistant by use of the PRWE and qDASH scores
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-50 years (to eliminate osteoporosis);
- •Primary non- or minimally displaced DRF;
- •Independent for activities of daily living.
排除标准
- •Fracture of the contralateral wrist;
- •Ipsilateral fractures, proximal of the DRF;
- •Pre-existent abnormalities or functional deficits of the fractured wrist;
- •Open fractures;
- •Polytrauma patients
- •Language disability to understand the Dutch patient information and questionnaires.
结局指标
主要结局
Patient Related Wrist Evaluation
时间窗: 6 months
The primary outcome measure is the PRWE (Patient Related Wrist Evaluation) score after six months. Patients rate their outcome on a 0-10 scale on pain and functional outcome, and scores will be transformed to a 0-100 score. A higher score indicates greater disability.
次要结局
- Patient Related Wrist Evaluation(6 weeks)
- Range of motion(6 weeks, 6 months)
- Radiological outcome(6 weeks, 6 months)
- Quick Disabilities of the Arm, Shoulder and Hand(6 weeks, 6 months)
- Pain/Visual analogue scale score(at emergency department (day 0-1), one week, 6 weeks, 6 months)
- Complications(6 weeks, 6 months)
- Cost-effectiveness(6 weeks, 6 months)