NCT05660031 Treatment of the Biceps With Concomitant Supraspinatus Tears
| NCT ID | NCT05660031 |
| Status | Recruiting |
| Phase | — |
| Sponsor | La Tour Hospital |
| Condition | Supraspinatus Tear |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2021-06-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology. Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact.
Eligibility Criteria
Inclusion Criteria: * Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy. * Full thickness tear of the supraspinatus tendon * Intact subscapularis tendon * Primary rotator cuff repair * Age 50-80 Exclusion Criteria: * Previous full thickness biceps tear * Infection and neuropathic joints * Known or suspected non-compliance, drug or alcohol abuse * Patients incapable of judgement or under tutelage * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for MRI scan etc. * Enrolment of the investigator, his/her family members, employees and other dependent persons * Patient declines to participate in study
Contact & Investigator
Alexandre Lädermann, MD
PRINCIPAL INVESTIGATOR
La Tour Hospital
Frequently Asked Questions
Who can join the NCT05660031 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Supraspinatus Tear. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05660031 currently recruiting?
Yes, NCT05660031 is actively recruiting participants. Contact the research team at alexandre.laedermann@gmail.com for enrollment information.
Where is the NCT05660031 trial being conducted?
This trial is being conducted at Ann Arbor, United States, Portland, United States, Calgary, Canada, Meyrin, Switzerland.
Who is sponsoring the NCT05660031 clinical trial?
NCT05660031 is sponsored by La Tour Hospital. The principal investigator is Alexandre Lädermann, MD at La Tour Hospital. The trial plans to enroll 180 participants.