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This is a prospective randomized study on using muscle tendons to repair tears of the muscles on the shoulder. There are 3 muscles covering the shoulder joint- supraspinatus, infraspinatus and subscapularis. Large tears involving these muscles can be treated by using some muscle from another location of the body known as Tendon transfer techniques. These muscle tendons may be from the lower back (Latissimus Dorsi), upper pack (lower trapezius) or chest (pectoralis). There are currently no studies to show which tendon transfer technique has better outcomes.
This study comprises two trials and a total of 84 participants would be enrolled. Each trial comparing the patient reported outcomes between two tendon transfer techniques. Large tears involving the supraspinatus and infraspinatus would be repaired using either the Latissimus dorsi technique or Lower trapezius technique. 21 patients would be randomly assigned to either groups. The second trial would be comparing the Latissimus dorsi technique and pectoralis technique in large tears of the subscapularis muscle. Another 21 patients would be randomly assigned to either groups.
The investigators are studying to see if the Lower Trapezius and Pectoralis transfer techniques for muscle tear repairs would have better post-surgical outcomes compared with Latissimus Dorsi transfer technique.
For both trials, participants would be followed up for 2 years and post-surgical outcomes would be compared between treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cuff tear without subscapularis tear-Lower Trapezius group | Active Comparator | Rotator cuff tears excluding the subscapularis muscle repaired using Lower Trapezius tendon |
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| Cuff tear without subscapularis tear-Latissimus Dorsi group | Active Comparator | Rotator cuff tears excluding the subscapularis muscle repaired using Latissimus Dorsi tendon |
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| Cuff tear involving subscapularis tear-Pectoralis group | Active Comparator | Rotator cuff tears involving the subscapularis muscle repaired using Pectoralis tendon |
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| Cuff tear involving subscapularis tear-Latissimus Dorsi group | Active Comparator | Rotator cuff tears involving the subscapularis muscle repaired using Latissimus Dorsi tendon |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower Trapezius Tendon Transfer Technique | Procedure | Lower Trapezius tendon used in repairing cuff tear |
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| Measure | Description | Time Frame |
|---|---|---|
| 12-point difference in American Shoulder and Elbow Surgeon (ASES) scores | The American Shoulder and Elbow Surgeon (ASES) score is a validated and reliable outcomes measure in patients with a wide variety of shoulder disorders. The ASES questionnaire examines two domains- pain (50 points) and function (50 points)- in a self-reported questionnaire and is scored on a 100-point scale. The minimum score is zero and the maximum is 100. A higher score means better outcome. | At one year post-operative follow-up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashfaq S Hasan, MD | U of Maryland Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U of Maryland Baltimore | Baltimore | Maryland | 21201 | United States |
No individual participant data will be shared
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| Latissimus Dorsi Tendon Transfer Technique | Procedure | Latissimus Dorsi tendon used in repairing cuff tear |
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| Pectoralis Tendon Transfer Technique | Procedure | Pectoralis tendon used in repairing cuff tear |
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