Actively Recruiting
Treatment of the Biceps With Concomitant Supraspinatus Tears: A Multicenter Pragmatic Three-Arm Parallel-Group Randomized Surgical Trial
Led by La Tour Hospital · Updated on 2025-04-25
180
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients aged 50 to 80 with a full-thickness supraspinatus tendon tear to compare three treatments for the long head of the biceps (LHB) tendon, which may cause shoulder pain and dysfunction in rotator cuff problems. The study aims to find out if LHB tenodesis offers better functional outcomes after surgery compared to LHB tenotomy or leaving the tendon intact. The trial also looks at differences in complications and patient satisfaction among these approaches. Participants will be randomly assigned to one of three groups: leaving the LHB tendon intact, performing an arthroscopic tenotomy where the tendon is cut at its origin, or performing an arthroscopic tenodesis where the tendon is cut and reattached using an onlay technique. All patients will undergo rotator cuff repair surgery. This study is conducted across multiple centers and uses a single-blind design to assess these surgical options. During the study, participants will be evaluated at various times, including 6 months and 24 months after surgery. Assessments include the ASES score, pain levels, shoulder function measures, tendon healing status, and any complications. Patient satisfaction and specific imaging findings related to the tendon and repair site will also be monitored. Follow-up will continue for up to two years to observe long-term outcomes and safety.
CONDITIONS
Brief Title
Treatment of the Biceps With Concomitant Supraspinatus Tears
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient voluntarily consents and can participate in study procedures and follow-up
- Full thickness tear of the supraspinatus tendon
- Intact subscapularis tendon
- Primary rotator cuff repair
- Age between 50 and 80 years
You will not qualify if you...
- Previous full thickness biceps tear
- Infection or neuropathic joints
- Known or suspected non-compliance or drug/alcohol abuse
- Incapable of judgement or under tutelage
- Unable to follow study procedures due to language, psychological, or other issues
- Investigator or related persons enrolled
- Patient declines to participate in study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and initial recovery period
Participants undergo rotator cuff repair surgery with one of three approaches to the long head of the biceps tendon: left intact, tenotomy, or tenodesis. Immediate post-operative care follows the surgery.
1 surgery visit and initial post-operative visits
Duration - Up to 24 months post-operative
Participants are monitored for functional outcomes, complications, and tendon status over the following months after surgery.
Multiple follow-up visits including assessments at 6 months and 24 months
Trial Site Locations
Total: 4 locations
1
Sports Medicine and Shoulder Surgery, University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
2
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
3
Group 23 Sports Medicine
Calgary, Alberta, Canada, T3B 6B7
Actively Recruiting
4
la Tour hospital
Meyrin, Canton of Geneva, Switzerland, 1217
Actively Recruiting
Research Team
A
Alexandre Lädermann, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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