Tenotomy Versus no Tenotomy LHB in Rotator Cuff Repair (NCT07289334) | Clinical Trial Compass
CompletedNot Applicable
Tenotomy Versus no Tenotomy LHB in Rotator Cuff Repair
60 participantsStarted 2015-01-01
Plain-language summary
The function of the long head of the biceps tendon (LHBT) in the glenohumeral joint generates controversy among researchers. For some, the tendon does not have a significant function in the shoulder, while others consider it acts as a depressor of the humeral head and a stabilizer of the joint. These functions may be enhanced in cases of rotator cuff injuries, where compensatory hypertrophy and/or instability of the LHBT can occur, which can also be a source of pain. One of the imaging techniques used for diagnosing these injuries is ultrasound.
Initially, G. Walch proposed tenotomy of the LHBT in massive rotator cuff tears to improve pain and, in some cases, shoulder function. Currently, many authors advocate tenotomy of the LHBT as an adjunct to rotator cuff repair to avoid postoperative pain. However, there is no evidence that this procedure improves the clinical outcomes of isolated rotator cuff repair.
Based on the pathophysiology of the LHBT associated with rotator cuff injuries and the current trend to perform tenotomies in conjunction with cuff repair, the objectives of this doctoral thesis project were:
To compare the clinical and imaging outcomes of arthroscopic rotator cuff repairs with and without LHBT tenotomy.
To analyze the position and cross-sectional area of the LHBT in the bicipital groove using ultrasound in cases with and without tenotomy.
Who can participate
Age range
40 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:
* Age between 40 and 65 years
* Partial supraspinatus tears (≥ 50% thickness)
* Complete supraspinatus tears ≤ 3 cm in the coronal plane
* Muscle atrophy less than stage 2 according to Thomazeau
* Presence of the LHBT in the bicipital groove
Exclusion Criteria:
* Patients younger than 40 or older than 65 years
* LHBT rupture
* Partial supraspinatus tears \< 50% thickness
* Supraspinatus tears \> 3 cm
* Tears of other rotator cuff tendons, with or without supraspinatus involvement
* Traumatic tears with surgery performed less than 3 months after injury
* Muscle atrophy ≥ stage 2 Thomazeau
* Associated degenerative glenohumeral pathology (\> Samilson 1)
* Previous shoulder surgeries
* Previous shoulder infections
* Associated peripheral neurological injuries
* Degenerative neurological conditions
* Patients who refused to sign informed consent
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.