Clinical Trial to Compare Clinical and Functional Results of the Augmentation of Supraspinatus Tears With the Long Head of the Biceps Brachii Tendon

Use of Long Head of bíceps Brachii Tendon as an Augmentation for Supraspinatus Tears: a Comparative Clinical Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tear Surgical Repair
• Intervention / Treatment: Procedure: Augmented supraspinatus repair; Procedure: Convencional Supraspinatus tear repair

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Active workers.
• A supraspinatus tear diagnosed in MRI.
• Modified Rohi equal or over 5 points.
• Failed conservative treatment (at least 3 months of phisiotherapy) or surgical indication secondary to acute traumatic tear with severe functional limitation.
• Age between 18 and 65.
• Long head of the biceps tendon pathology.
• Able to understand and sign the Informed Consent Form.

Exclusion Criteria:

• Tear of the subscapularis or infraspinatus tendon.
• Supraspinatus tears <1cm.
• Lack of long head of the biceps tendon.
• Rotator Cuff Arthropathy (Hamada >3).
• Glenohumeral osteoarthritis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotator Cuff Tear Augmented with Long head of the Biceps Tendon; After the supraspinsatus tendon repair, a piece of the tenotomized long head of the biceps tendon will be obtained and it will be prepared using a device to obtain a plain rectangular shaped graft that will be used to augment the supraspinatus.	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.
Active Comparator: Rotator Cuff Tear Without Augmentation; After the supraspinatus repair, a piece of the tenotomized long head of the biceps will be obtained but not used as a graft.	Procedure: Convencional Supraspinatus tear repair; A double row technique will be performed arthroscopically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant Murley Score	Shoulder specific clinical Score	From enrollment to the end of follow up at 1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASES score	American Shoulder and Elbow Score	From enrollment to 1 year after surgery
VAS	Pain scale	From enrollment to 1 year after surgery
Range of Motion	Motion	From enrollment to 1 year after surgery
Strenght in abduction		From enrollment to 1 year after surgery
Re-tear rate		From enrollment to 1 year after surgery
Satisfaction index	PASS score	From enrollment to 1 year after surgery

Other Outcome Measures

Outcome Measure	Time Frame
Time to return to work	From enrollment to 1 year after surgery

Collaborators and Investigators

• Sponsor: HOSPITAL FRATERNIDAD MUPRESPA HABANA

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 14, 2026
• First Submitted That Met QC Criteria: June 14, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Augmentation; Rotator cuff tear; Graft; Rotator cuff disease; Constant Murley Score; Long head of the biceps; Supraspinatus tear; Rotator cuff surgical treatment; Compressed long head of the biceps; Ases Score
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 23/654-E_Tesis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No