Tendon Transfer Rotator Cuff Tear

NCT04588506 | Terminated DMC

• 1 other identifier: HP-00091132
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Massive Rotator Cuff Tears; Tendon Transfer; Rotator Cuff Tears; Tendon Transfer Techniques

Outcome Measures

Primary Outcomes (1)

• 12-point difference in American Shoulder and Elbow Surgeon (ASES) scores

  The American Shoulder and Elbow Surgeon (ASES) score is a validated and reliable outcomes measure in patients with a wide variety of shoulder disorders. The ASES questionnaire examines two domains- pain (50 points) and function (50 points)- in a self-reported questionnaire and is scored on a 100-point scale. The minimum score is zero and the maximum is 100. A higher score means better outcome.

  At one year post-operative follow-up visit

Study Arms (4)

Cuff tear without subscapularis tear-Lower Trapezius group

ACTIVE COMPARATOR

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

Procedure: Lower Trapezius Tendon Transfer Technique

Cuff tear without subscapularis tear-Latissimus Dorsi group

ACTIVE COMPARATOR

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

Procedure: Latissimus Dorsi Tendon Transfer Technique

Cuff tear involving subscapularis tear-Pectoralis group

ACTIVE COMPARATOR

Rotator cuff tears involving the subscapularis muscle repaired using Pectoralis tendon

Procedure: Pectoralis Tendon Transfer Technique

Cuff tear involving subscapularis tear-Latissimus Dorsi group

ACTIVE COMPARATOR

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

Procedure: Latissimus Dorsi Tendon Transfer Technique

Interventions

Lower Trapezius Tendon Transfer Technique PROCEDURE

Lower Trapezius tendon used in repairing cuff tear

Cuff tear without subscapularis tear-Lower Trapezius group

Latissimus Dorsi Tendon Transfer Technique PROCEDURE

Latissimus Dorsi tendon used in repairing cuff tear

Cuff tear involving subscapularis tear-Latissimus Dorsi group; Cuff tear without subscapularis tear-Latissimus Dorsi group

Pectoralis Tendon Transfer Technique PROCEDURE

Pectoralis tendon used in repairing cuff tear

Cuff tear involving subscapularis tear-Pectoralis group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

U of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Ashfaq S Hasan, MD

  U of Maryland Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 19, 2020
• Study Start: February 15, 2022
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)