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NCT Number: NCT07657689

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

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.

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Key information

Conditions

Rotator Cuff Tear Surgical Repair Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Augmented supraspinatus repair

Procedure

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.

Convencional Supraspinatus tear repair

Procedure

A double row technique will be performed arthroscopically.

Primary outcomes

  1. Constant Murley Score

    Time frame: From enrollment to the end of follow up at 1 year after surgery

    Shoulder specific clinical Score

Secondary outcomes

  1. ASES score

    Time frame: From enrollment to 1 year after surgery

    American Shoulder and Elbow Score

  2. VAS

    Time frame: From enrollment to 1 year after surgery

    Pain scale

  3. Range of Motion

    Time frame: From enrollment to 1 year after surgery

    Motion

  4. Strenght in abduction

    Time frame: From enrollment to 1 year after surgery

  5. Re-tear rate

    Time frame: From enrollment to 1 year after surgery

  6. Satisfaction index

    Time frame: From enrollment to 1 year after surgery

    PASS score

Other outcomes

  1. Time to return to work

    Time frame: From enrollment to 1 year after surgery

Sponsors and collaborators

Lead sponsor

HOSPITAL FRATERNIDAD MUPRESPA HABANA

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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