Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures Operated by Internal Fixation With Volar Locking Plate: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Function in Patient Rated Wrist Evaluation Scale.
研究概览
简要总结
The aim of this study is to compare functional and radiological results in two groups of distal radius fractures treated with internal fixation with locking plate, and immobilized with antebrachial splint or compression bandage for 3 weeks.
详细描述
The aim of the study is to compare functional and radiological results as well as to evaluate possible complications in distal radius fractures operated by open reduction and internal fixation with volar locking plate in two groups , one treated with immobilization using a forearm cast for 3 weeks and the other with immobilization using a compression bandage for 3 weeks, based on the hypothesis that compression bandage group could obtain better results in the short term, and none of the treatments is superior to the other after 3 or 6 months of evolution, as indicated by some reviewed studies.
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
Patient receive the correspondant treatment based on the order of an aleatory numbers table
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type A, B, C fractures of AO classification of distal radius fractures
- •Patents aged between 18 and 75 years,
- •Patients operated on in the first 3 weeks after the trauma, and independent for the basic activities of daily living
排除标准
- •Patients with open fractures
- •Patients with mental disorders (dementia, alcoholism, etc.),
- •Patient dependent for basic activities of daily living
- •Patients with fractures with severe articular and metaphyseal comminution and/or severe soft tissue injuries (type 2R3C3 AO),
- •Patients with previous diseases or anatomical alterations in the injured wrist (previous fractures, rheumatoid arthritis, etc.).
结局指标
主要结局
Function in Patient Rated Wrist Evaluation Scale.
时间窗: 1 year
Points from 1 to 100. Higher score: worse value. Lower score: better value.
Pain in Visual Analogue Scale.
时间窗: 1 year
Points from 1 to 10. Higher score: worse value. Lower score: better value.
Range Of Motion in Flexion.
时间窗: 1 year
Grades from 0 to 70. Higher score: better value. Lower score: worse value.
次要结局
- Function in Disabilities of Arm, Shoulder and Hand Scale.(1 year)
- Function in Mayo Wrist Score Scale.(1 year)
- Range of motion in Supination.(1 year)
- Number of participants with posoperative complications.(1 year)
- Number of posoperative Fisiotherapy sessions performed.(1 year)
- Grades of Dorsal Displacement in fracture.(6 weeks)
- Range of motion in Pronation.(1 year)
- Range of motion in Radial Deviation(1 year)
- Time of fracture union in radiographs.(12 weeks)
- Number of Instability distal radius fracture Criteria per participant.(1 year)
- Range of motion in Ulnar deviation.(1 year)
- Number of shortening millimeters in fracture.(6 weeks)
- Number of ulnar variance millimeters in fracture.(6 weeks)
- Number of step-off millimeters in fracture.(6 weeks)