Clinical Trial to Compare Clinical and Functional Results of the Augmentation of Supraspinatus Tears With the Long Head of the Biceps Brachii Tendon
NCT07657689 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-06-18
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.
Conditions
- Rotator Cuff Tear Surgical Repair
Interventions
- PROCEDURE
-
Augmented supraspinatus repair
After conventional arthroscopic repair of the supraspinsatus with a double row technique, an autologous graft obtained from the long head of the biceps will be used as a Graf to improve biological properties of the supraspinatus tear; aiming to reduce re-tears and to improve Clinical results.
- PROCEDURE
-
Convencional Supraspinatus tear repair
A double row technique will be performed arthroscopically.
Sponsors & Collaborators
-
HOSPITAL FRATERNIDAD MUPRESPA HABANA
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2027-06-30
- Completion
- 2028-06-30
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