Clinical Trial to Compare Clinical and Functional Results of the Augmentation of Supraspinatus Tears With the Long Head of the Biceps Brachii Tendon
Use of Long Head of bíceps Brachii Tendon as an Augmentation for Supraspinatus Tears: a Comparative Clinical Trial.
The goal of this clinical trial is to reduce the risk for re-tear in rotator cuff surgeries and improve clinical results in a working age population. The main questions it aims to answer are:
If we can improve surgical results using the long head of the biceps tendon as a graft.
If we can reduce the risk of re-tear using the long head of the biceps tendon as a graft.
Researchers will compare participants with rotator cuff tears with two different surgical techniques to see if their clinical results improve using the long head of the biceps tendon as a graft compared with not using a graft.
Participants will be asked to get enrolled in the study not knowing in which group they will be assigned to by signing a Informed Consent Form and both groups would have the same follow up conditions and treatment.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Active workers.
- A supraspinatus tear diagnosed in MRI.
- Modified Rohi equal or over 5 points.
- Failed conservative treatment (at least 3 months of phisiotherapy) or surgical indication secondary to acute traumatic tear with severe functional limitation.
- Age between 18 and 65.
- Long head of the biceps tendon pathology.
- Able to understand and sign the Informed Consent Form.
Exclusion Criteria:
- Tear of the subscapularis or infraspinatus tendon.
- Supraspinatus tears <1cm.
- Lack of long head of the biceps tendon.
- Rotator Cuff Arthropathy (Hamada >3).
- Glenohumeral osteoarthritis.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Rotator Cuff Tear Augmented with Long head of the Biceps Tendon
After the supraspinsatus tendon repair, a piece of the tenotomized long head of the biceps tendon will be obtained and it will be prepared using a device to obtain a plain rectangular shaped graft that will be used to augment the supraspinatus.
|
After conventional arthroscopic repair of the supraspinsatus with a double row technique, an autologous graft obtained from the long head of the biceps will be used as a Graf to improve biological properties of the supraspinatus tear; aiming to reduce re-tears and to improve Clinical results.
|
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有源比较器：Rotator Cuff Tear Without Augmentation
After the supraspinatus repair, a piece of the tenotomized long head of the biceps will be obtained but not used as a graft.
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A double row technique will be performed arthroscopically.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Constant Murley Score
大体时间：From enrollment to the end of follow up at 1 year after surgery
|
Shoulder specific clinical Score
|
From enrollment to the end of follow up at 1 year after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ASES score
大体时间：From enrollment to 1 year after surgery
|
American Shoulder and Elbow Score
|
From enrollment to 1 year after surgery
|
|
VAS
大体时间：From enrollment to 1 year after surgery
|
Pain scale
|
From enrollment to 1 year after surgery
|
|
Range of Motion
大体时间：From enrollment to 1 year after surgery
|
Motion
|
From enrollment to 1 year after surgery
|
|
Strenght in abduction
大体时间：From enrollment to 1 year after surgery
|
From enrollment to 1 year after surgery
|
|
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Re-tear rate
大体时间：From enrollment to 1 year after surgery
|
From enrollment to 1 year after surgery
|
|
|
Satisfaction index
大体时间：From enrollment to 1 year after surgery
|
PASS score
|
From enrollment to 1 year after surgery
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
Time to return to work
大体时间：From enrollment to 1 year after surgery
|
From enrollment to 1 year after surgery
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 23/654-E_Tesis
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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