Rotator Cuff Tears Treated With Long Head of the Biceps Reinforcement (NCT06664645) | Clinical Trial Compass
CompletedNot Applicable
Rotator Cuff Tears Treated With Long Head of the Biceps Reinforcement
Brazil60 participantsStarted 2022-01-14
Plain-language summary
The increase of the population life expectancy and the active lifestyle adopted in recent years have contributed to the higher incidence of rotator cuff injuries. For large (\>3 cm) and extensive (\>5 cm) injuries of the rotator cuff, even after complete or partial repair, the chances of failure reach 94%.
An alternative in rotator cuff injuries is the use of the long head of the biceps (LHB) as an autologous graft to increase the healing rate and the final outcomes.
The primary objective is to compare the functional results, according to the ASES score, between patients who use or not the long head biceps brace for complete repairs of large and extensive rotator cuff tears.
The secondary objectives are to compare the groups according to structural results by MRI and functional results by the UCLA score.
Who can participate
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:
* Long head tendon of biceps intact;
* Large or extensive posterosuperior rotator cuff injuries according to the classification of DeOrio and Cofield;20
* Fatty degeneration of the ≦2 supraspinatus muscle according to the classification of Goutallier.21
Exclusion Criteria:
* Active or previous infection in the affected shoulder;
* Patients unable to understand preoperative questionnaires;
* Patient who does not undergo at least 1 postoperative evaluation.
* Injury where complete repair of the rotator cuff is not possible;
* Rupture of the LHB tendon diagnosed intraoperatively.
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.