Clinical Trials Directory

Trials / Terminated

TerminatedNCT04588506

Tendon Transfer Rotator Cuff Tear

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
University of Maryland, Baltimore · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDURELower Trapezius Tendon Transfer TechniqueLower Trapezius tendon used in repairing cuff tear
PROCEDURELatissimus Dorsi Tendon Transfer TechniqueLatissimus Dorsi tendon used in repairing cuff tear
PROCEDUREPectoralis Tendon Transfer TechniquePectoralis tendon used in repairing cuff tear

Timeline

Start date
2022-02-15
Primary completion
2024-12-11
Completion
2024-12-11
First posted
2020-10-19
Last updated
2025-06-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04588506. Inclusion in this directory is not an endorsement.