Home › NCT05660031
Treatment of the Biceps With Concomitant Supraspinatus Tears
Treatment of the Biceps With Concomitant Supraspinatus Tears: A Multicenter Pragmatic Three-Arm Parallel-Group Randomized Surgical Trial
Who can join
Ages 50 to 80 · All sexes
Full 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
About the study
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.
What is being tested
- LHB Tenotomy (procedure)
- LHB Tenodesis (procedure)
Sponsor: La Tour Hospital · Participants: 180 · Started: Jun 1, 2021
Contact the study team
- Alexandre Lädermann, MD · Phone: +41 22 71 975 55
Official record on ClinicalTrials.gov — NCT05660031
Locations in the U.S.
| Michigan | Sports Medicine and Shoulder Surgery, University of Michigan, Ann Arbor |
| Oregon | Oregon Health & Science University, Portland |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.