Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate - a Study Protocol for a Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 9
- 主要终点
- Patient-rated wrist evaluation questionnaire
研究概览
简要总结
The aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.
详细描述
This study is a prospective, randomized, controlled trial. The aim of this study will be to compare the early postoperative outcomes of the patients enrolled in the early mobilization with those patients in post-operative 2-week casting following volar plating for a DRF. Co-primary outcome in this study will be the total lenght of sick leave and Patient-Rated Wrist Evaluation (PRWE) 2 months after the operation.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intra- or extra articular DRF (Colles, Smith, Volar barton)
- •operative treatment justified
排除标准
- •Refusal to participate in the study
- •Open fracture with a severity greater than Gustilo grade 1
- •Patient aged less than 18 or over 65
- •Patient does not understand written or spoken guidance in local languages
- •Pathological fracture
- •Previous fracture in the same wrist or forearm in the last 10 years, that has led to impairment of function
- •Ipsilateral fracture in upper extremity
- •Associated fractures of the ulna (except fractures of the PSU)
- •Polytrauma
研究组 & 干预措施
Immediate mobilization after distal radius fracture treated with volar locking plate
干预措施: Immediate mobilization (Other)
Immediate mobilization after distal radius fracture treated with volar locking plate
干预措施: Volar plating (Procedure)
2 weeks cast immobilization after distal radius fracture treated with volar locking plate
干预措施: Cast treatment (Other)
2 weeks cast immobilization after distal radius fracture treated with volar locking plate
干预措施: Volar plating (Procedure)
结局指标
主要结局
Patient-rated wrist evaluation questionnaire
时间窗: 2 months
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.
Total lenght of the sick leave
时间窗: 12 months
Total number of days of work during the 1 year study period
次要结局
- Self-perceived working ability(12 months)
- Patient-rated wrist evaluation questionnaire(12 months)
- Return to work(12 months)
- Complications(12 months)
- Work capacity(12 months)
- Visual analogue pain scale(12 months)
- Patient-acceptable symptom state(12 months)
- Patient-rated wrist evaluation questionnaire(4 weeks)
- Patient-rated wrist evaluation questionnaire(6 months)
- Return to work(4 weeks)
- Return to work(2 months)
- Return to work(6 months)
- Complications(4 weeks)
- Complications(2 months)
- Complications(6 months)
- Self-perceived working ability(4 weeks)
- Self-perceived working ability(2 months)
- Self-perceived working ability(6 months)
- Visual analogue pain scale(4 weeks)
- Visual analogue pain scale(2 months)
- Visual analogue pain scale(6 months)
- Patient-acceptable symptom state(2 months)
- Patient-acceptable symptom state(6 months)
- Work capacity(4 weeks)
- Work capacity(2 months)
- Work capacity(6 months)
研究者
Aleksi Reito
Associate professor
Tampere University Hospital