TERMINATED

Tendon Transfer Rotator Cuff Tear

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-15
Study Completion:2024-12-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04588506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects must have massive, irreparable tear of the posterior-superior rotator cuff
  2. * Subjects between 18 years and 65 years (≥ 18 and ≤ 65 years of age).
  3. * Diagnosis of no to minimal glenohumeral arthritis- Hamada 1 and 2
  4. * Subject with irreparable subscapularis tendon tear (Arms 3 and 4 ONLY)
  1. * Subjects having severe glenohumeral arthritis
  2. * History of prior tendon transfer
  3. * Axillary nerve injury
  4. * Deltoid deficiency
  5. * Subjects with pseudo paralysis
  6. * History of post-operative deep shoulder infection
  7. * Non-English-speaking subjects.
  8. * Subject has any condition, that in the opinion of the investigator, would prevent them from completing this study
  9. * Subject with irreparable subscapularis tendon tear (Arms 1 and 2 ONLY)

Contacts and Locations

Principal Investigator

Ashfaq S Hasan, MD
PRINCIPAL_INVESTIGATOR
U of Maryland Baltimore

Study Locations (Sites)

U of Maryland Baltimore
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

  • Ashfaq S Hasan, MD, PRINCIPAL_INVESTIGATOR, U of Maryland Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-15
Study Completion Date2024-12-11

Study Record Updates

Study Start Date2022-02-15
Study Completion Date2024-12-11

Terms related to this study

Keywords Provided by Researchers

  • Massive Rotator Cuff Tears
  • Tendon Transfer
  • Rotator Cuff Tears
  • Tendon Transfer Techniques

Additional Relevant MeSH Terms

  • Rotator Cuff Tears