The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Disablities of Arm, Hand and Shoulder
研究概览
简要总结
Open reduction and locking plate osteosynthesis is a commonly used and well-accepted treatment for displaced fractures of the proximal humerus. The shoulders tend to end stiff despite intensive rehabilitation, limiting the function of the upper extremity and decreasing the quality of life. The accepted postoperative mobilisation protocol includes passive exercises until six weeks postoperatively and active range of motion exercises after that. There is good evidence that conservatively treated fractures of the same site heal better and faster if mobilised immediately. The study compares "standard mobilisation" versus "immmediate mobilisation" in a prospective, randomized, controlled trial in order to find the optimal time-frame for physiotherapy to produce best possible results. Outcome measures are assessed at specific time points after the operation and comparisons between groups are made to follow the rate of recovery and end results.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Surgery can be performed within 10 days of injury
- •A dislocated (>1cm or 35 degrees) AO 11-A2, -A3, -B1 or -B2 fracture of the surgical neck of the proximal humerus with a possible fracture of the Tuberculum Majus
排除标准
- •Glenohumeral dislocation
- •Fracture of the Tuberculum Minus
- •Open fracture
- •Additional fractures in the shoulder region
- •Other injuries requiring surgical treatment
- •Clinically significant injury of the brachial plexus or vasculature
- •Pathological fracture associated with cancer
- •History of a fracture of the clavicle, scapula or humerus, or history of a very significant disease or trauma of the shoulder region (hemiparesis, tumour, osteomyelitis, grave arthrosis etc)
- •Rheumatoid Arthritis in the shoulder requiring active treatment
- •Reduced co-operation or incapability for independent living (dementia, mental illness, drug- or alcohol abuse etc)
- •Unwillingness to accept some of the treatment options.
结局指标
主要结局
Disablities of Arm, Hand and Shoulder
时间窗: 2 years
Validated patient-reported upper extremity function scale
次要结局
- Constant Score(3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Simple Shoulder Test (SST)(3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Pain in rest and motion (2 different values)(3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Subjective satisfaction(3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Quality of Life(3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Complications(3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years)
研究者
Tuomas Lahdeoja
MD
University of Helsinki