Comparison of Functional and Patient-reported Outcome Using Continuous Passive Motion in Rehabilitation After Plate Osteosynthesis of Proximal Humerus Fractures
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Change of Disabilities of Arm, Shoulder and Hand Score (DASH) after 6 weeks, 12 weeks and 1 year
研究概览
简要总结
Patients suffering from a proximal humerus fracture treated with plate osteosynthesis will receive either regular aftercare (physiotherapy) or aftercare assisted with continous passive motion (physiotherapy + CPM). Change in functional and patient-reported outcome (PROM) over time will be evaluated and compared.
详细描述
The investigators will conduct a prospective, monocentric study focusing on the rehabilitation process after surgical treatment of proximal humerus fractures. Patients treated with plate osteosynthesis and eligible to participate will be randomly assigend to either a regular rehabilitation protocol (immobilization and physiotherapy) or a rehabilitation protocol with the additional use of a continous passive motion device (immobilization, physiotherapy and CPM).
After 6 and 12 weeks as well as 1 year in a follow-up examination functional (range of motion) and patient-reported outcome (Disabilities of Arm, Shoulder and Hand Score [DASH], Constant-Score, pain on visual analogue scale, subjective satisfaction) will be evaluated. Results will be compared towards possible differences and effect of CPM therapy. In addition demographic factors (age, sex, BMI, etc.) and complications will be analysed.
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
盲法说明
Patients are randomly assigend, masking is not possible.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with proximal humeral fracture treated with plate osteosynthesis during the enrollment period
- •understanding of German language (written and oral)
- •written informed consent of the patient or the legal guardian
排除标准
- •patients not meeting the aforementioned criteria
- •patients with the need of / or an already existing endoprosthesis
- •patients with ipsilateral fracture of the distal radius
- •patients with cerebral damage (contusio or commotio cerebri)
- •patients with affection of the brachial plexus or nerve palsy
- •non-compliance
结局指标
主要结局
Change of Disabilities of Arm, Shoulder and Hand Score (DASH) after 6 weeks, 12 weeks and 1 year
时间窗: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Evaluation of the subjective function (patient reported outcome) using the DASH-Score, 0-100, best: 0, worst: 100
Change of Subjective satisfaction with surgical treatment (SSV) after 6 weeks, 12 weeks and 1 year
时间窗: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Evaluation of the subjective satisfaction using the subjective shoulder value, 0-100, best:100, worst: 0
Change of Pain on visual analogue scale (VAS) after 6 weeks, 12 weeks and 1 year
时间窗: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Evaluation of the subjective pain using a visual analogue scale, 0-10, best:0, worst: 10
Change of Constant-Score (CSS) after 6 weeks, 12 weeks and 1 year
时间窗: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Evaluation of the subjective function (patient reported outcome) using the Constant-Score, 0-100, best: 100, worst: 0
Change in Range of Motion (ROM) after 6 weeks, 12 weeks and 1 year
时间窗: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Objetive functional clinical result. Evaluation ot Motion of the shoulder in ° measured via goniometer. Physiological Abduction/Adduction: 180/0/40°, Anteversion/Retroversion 160/0/40°, external/internal rotation: 70/0/60°
次要结局
- Influence of demographic factors upon rehabilitation process(Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment)