Results of Arthroscopic Massive Rotator Cuff Tears Repair With Or Without Superior Capsular Augmentation Using Proximal Part Of Long Head Of Biceps Tendon: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Functional shoulder constant score (assess the change pre operative and post operative during study period completion)
研究概览
简要总结
The Goal of this clinical trial is to asses the function of arthroscopic repair with or without superior capsular augmentation using biceps tendon .
详细描述
All patients included in this clinical trial Will be informed by written consent will undergo a one week screening to determine the eligibility for study entry. Patients who meet the eligibility requirements Will be randomised in a single blinded manner ( patients).
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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 40 to 80 years old
- •Patients with massive rotator cuff tear
排除标准
- •patients with glenohumeral arthritis
- •Acromioclavicular arthritis that requires distal clavicle resection
- •Patients with other intra articular pathology like slap lesion
- •Neural damage( brachial plexus injury)
- •Revision cases
结局指标
主要结局
Functional shoulder constant score (assess the change pre operative and post operative during study period completion)
时间窗: 1- preoperative 2- six months post operative 3- one year post operative
Assess the change of Constant score of the patients pre operative and during follow up duration of the study on multiple periods (a multi-item functional scale assessing pain, activity of daily living , range of motion and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively.)
Functional shoulder ases score (assess the change preoperative and postoperative during study period completion )
时间窗: 1- preoperative 2- six months post operative 3- one year post operative
Assess the change in Ases score pre operative and post operative during study completion on multiple periods ( American shoulder and elbow surgeons standardized form)Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
次要结局
- Shoulder Pain ( assess the change preoperative and postoperative during the study period completion)(1 pre operative 2 two weeks post operative 3 six months post operative)