Tendon Transfer Rotator Cuff Tear

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04588506
• Other study ID #: HP-00091132
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: University of Maryland, Baltimore
• Contact: Ashfaq S Hasan, MD
• Phone: 410-402-0640
• Email: ahassan[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Procedure:
• Lower Trapezius Tendon Transfer Technique
Lower Trapezius tendon used in repairing cuff tear
• Latissimus Dorsi Tendon Transfer Technique
Latissimus Dorsi tendon used in repairing cuff tear
• Pectoralis Tendon Transfer Technique
Pectoralis tendon used in repairing cuff tear

Locations

Country	Name	City	State
United States	U of Maryland Baltimore	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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