TerminatedNot Applicable

Tendon Transfer Rotator Cuff Tear

Stopped: Lack of enrollment

United States10 participantsStarted 2022-02-15

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects must have massive, irreparable tear of the posterior-superior rotator cuff * Subjects between 18 years and 65 years (≥ 18 and ≤ 65 years of age). * Diagnosis of no to minimal glenohumeral arthritis- Hamada 1 and 2 * Subject with irreparable subscapularis tendon tear (Arms 3 and 4 ONLY) Exclusion Criteria: * Subjects having severe glenohumeral arthritis * History of prior tendon transfer * Axillary nerve injury * Deltoid deficiency * Subjects with pseudo paralysis * History of post-operative deep shoulder infection * Non-English-speaking subjects. * Subject has any condition, that in the opinion of the investigator, would prevent them from completing this study * Subject with irreparable subscapularis tendon tear (Arms 1 and 2 ONLY)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

12-point difference in American Shoulder and Elbow Surgeon (ASES) scores

Timeframe: At one year post-operative follow-up visit

Trial details

NCT IDNCT04588506

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-11

View on ClinicalTrials.gov More Rotator Cuff Tears trials