Tendon Transfer Rotator Cuff Tear

NCT ID: NCT04588506

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2024-12-11

Brief Summary

This is a prospective randomized study on using muscle tendons to repair tears of the muscles on the shoulder. There are 3 muscles covering the shoulder joint- supraspinatus, infraspinatus and subscapularis. Large tears involving these muscles can be treated by using some muscle from another location of the body known as Tendon transfer techniques. These muscle tendons may be from the lower back (Latissimus Dorsi), upper pack (lower trapezius) or chest (pectoralis). There are currently no studies to show which tendon transfer technique has better outcomes.

This study comprises two trials and a total of 84 participants would be enrolled. Each trial comparing the patient reported outcomes between two tendon transfer techniques. Large tears involving the supraspinatus and infraspinatus would be repaired using either the Latissimus dorsi technique or Lower trapezius technique. 21 patients would be randomly assigned to either groups. The second trial would be comparing the Latissimus dorsi technique and pectoralis technique in large tears of the subscapularis muscle. Another 21 patients would be randomly assigned to either groups.

The investigators are studying to see if the Lower Trapezius and Pectoralis transfer techniques for muscle tear repairs would have better post-surgical outcomes compared with Latissimus Dorsi transfer technique.

For both trials, participants would be followed up for 2 years and post-surgical outcomes would be compared between treatment groups.

Conditions

Rotator Cuff Tears

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cuff tear without subscapularis tear-Lower Trapezius group

Rotator cuff tears excluding the subscapularis muscle repaired using Lower Trapezius tendon

Group Type: ACTIVE_COMPARATOR

Lower Trapezius Tendon Transfer Technique

Intervention Type: PROCEDURE

Lower Trapezius tendon used in repairing cuff tear

Cuff tear without subscapularis tear-Latissimus Dorsi group

Rotator cuff tears excluding the subscapularis muscle repaired using Latissimus Dorsi tendon

Group Type: ACTIVE_COMPARATOR

Latissimus Dorsi Tendon Transfer Technique

Intervention Type: PROCEDURE

Latissimus Dorsi tendon used in repairing cuff tear

Cuff tear involving subscapularis tear-Pectoralis group

Rotator cuff tears involving the subscapularis muscle repaired using Pectoralis tendon

Group Type: ACTIVE_COMPARATOR

Pectoralis Tendon Transfer Technique

Intervention Type: PROCEDURE

Pectoralis tendon used in repairing cuff tear

Cuff tear involving subscapularis tear-Latissimus Dorsi group

Rotator cuff tears involving the subscapularis muscle repaired using Latissimus Dorsi tendon

Group Type: ACTIVE_COMPARATOR

Latissimus Dorsi Tendon Transfer Technique

Intervention Type: PROCEDURE

Latissimus Dorsi tendon used in repairing cuff tear

Interventions

Lower Trapezius Tendon Transfer Technique

Lower Trapezius tendon used in repairing cuff tear

Intervention Type: PROCEDURE

Latissimus Dorsi Tendon Transfer Technique

Latissimus Dorsi tendon used in repairing cuff tear

Intervention Type: PROCEDURE

Pectoralis Tendon Transfer Technique

Pectoralis tendon used in repairing cuff tear

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subjects must have massive, irreparable tear of the posterior-superior rotator cuff
• Subjects between 18 years and 65 years (≥ 18 and ≤ 65 years of age).
• Diagnosis of no to minimal glenohumeral arthritis- Hamada 1 and 2
• Subject with irreparable subscapularis tendon tear (Arms 3 and 4 ONLY)

Exclusion Criteria

• Subjects having severe glenohumeral arthritis
• History of prior tendon transfer
• Axillary nerve injury
• Deltoid deficiency
• Subjects with pseudo paralysis
• History of post-operative deep shoulder infection
• Non-English-speaking subjects.
• Subject has any condition, that in the opinion of the investigator, would prevent them from completing this study
• Subject with irreparable subscapularis tendon tear (Arms 1 and 2 ONLY)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Ashfaq Hasan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashfaq S Hasan, MD

Role: PRINCIPAL_INVESTIGATOR

U of Maryland Baltimore

Locations

U of Maryland Baltimore

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00091132

Identifier Type: -

Identifier Source: org_study_id