Tendon Transfer Rotator Cuff Tear

Tendon Transfer Techniques for Massive Rotator Cuff Tear Repairs: An Integrated Prospective Randomized Multicenter Trial

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.

Study Overview

• Status: Terminated
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Procedure: Lower Trapezius Tendon Transfer Technique; Procedure: Latissimus Dorsi Tendon Transfer Technique; Procedure: Pectoralis Tendon Transfer Technique

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • U of Maryland Baltimore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cuff tear without subscapularis tear-Lower Trapezius group; Rotator cuff tears excluding the subscapularis muscle repaired using Lower Trapezius tendon	Procedure: Lower Trapezius Tendon Transfer Technique; Lower Trapezius tendon used in repairing cuff tear
Active Comparator: Cuff tear without subscapularis tear-Latissimus Dorsi group; Rotator cuff tears excluding the subscapularis muscle repaired using Latissimus Dorsi tendon	Procedure: Latissimus Dorsi Tendon Transfer Technique; Latissimus Dorsi tendon used in repairing cuff tear
Active Comparator: Cuff tear involving subscapularis tear-Pectoralis group; Rotator cuff tears involving the subscapularis muscle repaired using Pectoralis tendon	Procedure: Pectoralis Tendon Transfer Technique; Pectoralis tendon used in repairing cuff tear
Active Comparator: Cuff tear involving subscapularis tear-Latissimus Dorsi group; Rotator cuff tears involving the subscapularis muscle repaired using Latissimus Dorsi tendon	Procedure: Latissimus Dorsi Tendon Transfer Technique; Latissimus Dorsi tendon used in repairing cuff tear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Ashfaq S Hasan, MD, U of Maryland Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): December 11, 2024
• Study Completion (Actual): December 11, 2024

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Rotator Cuff Tears; Massive Rotator Cuff Tears; Tendon Transfer; Tendon Transfer Techniques
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: HP-00091132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No