Evaluation of Functionality, Operability and Wearing Comfort of Two Multifunctional Shoulder Braces in Patients Who Underwent Shoulder Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Overall wearing comfort subjectively reported by patients
研究概览
简要总结
Shoulder orthoses are an essential component of both, postoperative care as well as a range of conservative treatment concepts, and thus influence the functional outcome of a wide spectrum of glenohumeral pathologies. Therefore it is important to look at them in greater detail.
A new concept, designed by DJO Global in the "Ultrasling Quadrant®" orthosis now immobilizes only the glenohumeral joint, while giving the possibility of elbow movement. It also allows multiple settings concerning the position of the glenohumeral joint like internal rotation as well as neutral or external rotation. It is yet to be seen how these changes will influence the outcome of therapy as well as how they will change the patient's perception of the orthosis and its wearing comfort. Therefore it is planned to be compared to another multifunctional shoulder brace already established on the domestic and international market, the BledsoeARC® brace.
The primary objective is to assess if one of the investigated shoulder braces Ultrasling Quadrant® or Bledsoe Arc® is perceived by patients who received shoulder surgery as superior in terms of higher wearing comfort when worn during the post-operative immobilization period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patient (18 years or older)
- •Presence of one of the following defined shoulder pathologies with the corresponding surgical treatment:
- •Patients with isolated supraspinatus repairs in double row technique with or without biceps Treatment
- •Recurrent anterior instability without significant bone loss and arthroscopic Bankart repairs with three anchors
- •Rockwood Type V injury treated with arthroscopic-assisted low-profile TightRope Repair plus AC-Cerclage
- •Patients with rotator cuff arthropathy treated by reverse shoulder prosthesis
- •Signed Informed Consent to participate in the study
排除标准
- •Non-tolerance of one of the braces (e.g. allergy to textile component)
- •Presence of concurrent pathology of the contralateral arm , that interferes with the immobilizing treatment
- •Presence of another physical disability or health disorder (e.g. psychological disorders, dementia, ...) that make the handling of the braces more difficult or impossible
- •Patient perceived as being at risk of poor study compliance
- •Occurrence of an intra-operative adverse event likely to influence the post-operative immobilization and its evaluation
- •Inability to understand and speak German
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
研究组 & 干预措施
Invervention 1
Immobilization with the Ultrasling® Quadrant shoulder brace after surgical treatment.
干预措施: Ultrasling® Quadrant (Device)
Intervention 2 (Control)
Immobilization with the Bledsoe ARC® brace after surgical treatment.
干预措施: Bledsoe ARC® (Device)
结局指标
主要结局
Overall wearing comfort subjectively reported by patients
时间窗: 2 weeks
The primary outcome for this study is the overall level of comfort as perceived subjectively by the patients themselves by a questionnaire (NRS based).
次要结局
- Operability(2 weeks)
- Pain in ADL(2 weeks)
- Stability(2 weeks)
- Compliance(2 weeks)
- Difficulty(2 weeks)
- Comfort(2 weeks)
- Patient's preference for any of the two braces(2 weeks)