Clinical Trial to Compare Clinical and Functional Results of the Augmentation of Supraspinatus Te… (NCT07657689) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Trial to Compare Clinical and Functional Results of the Augmentation of Supraspinatus Tears With the Long Head of the Biceps Brachii Tendon
90 participantsStarted 2026-06
Plain-language summary
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.
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:
* 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.
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.
1This trial is comparing two surgical approaches for supraspinatus tears — one using the long head of the biceps tendon as an augmentation — how does that technique differ from the standard repair my surgeon would normally perform on me?
2Since this trial is listed as 'not yet recruiting,' when is it expected to open, and would waiting for it to start delay my treatment in a way that could affect my shoulder's recovery?
3The trial is measuring outcomes using the Constant Murley Score — can you explain what that measures and whether it captures the specific functional goals that matter most to me, like returning to work or a particular activity?
4Because this is listed as Phase NA, which sometimes means it's a surgical or procedural comparison study rather than a drug trial, what does that mean for how much is already known about the safety of using the biceps tendon this way?
5If I were to consider this trial once it opens, what would happen to my long head of the biceps tendon long-term, and is there a standard-of-care option I should think about first while the trial gets underway?
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
1
Constant Murley Score
Timeframe: From enrollment to the end of follow up at 1 year after surgery