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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotator Cuff Tear Augmented with Long head of the Biceps Tendon | Experimental | 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. |
|
| Rotator Cuff Tear Without Augmentation | Active Comparator | After the supraspinatus repair, a piece of the tenotomized long head of the biceps will be obtained but not used as a graft. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented supraspinatus repair | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Constant Murley Score | Shoulder specific clinical Score | From enrollment to the end of follow up at 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| ASES score | American Shoulder and Elbow Score | From enrollment to 1 year after surgery |
| VAS | Pain scale | From enrollment to 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to return to work | From enrollment to 1 year after surgery |
Inclusion Criteria:
Exclusion Criteria:
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|
| Convencional Supraspinatus tear repair | Procedure | A double row technique will be performed arthroscopically. |
|
| Range of Motion | Motion | From enrollment to 1 year after surgery |
| Strenght in abduction | From enrollment to 1 year after surgery |
| Re-tear rate | From enrollment to 1 year after surgery |
| Satisfaction index | PASS score | From enrollment to 1 year after surgery |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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