search
Back to results

Tendon Transfer Rotator Cuff Tear

Primary Purpose

Rotator Cuff Tears

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lower Trapezius Tendon Transfer Technique
Latissimus Dorsi Tendon Transfer Technique
Pectoralis Tendon Transfer Technique
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring Massive Rotator Cuff Tears, Tendon Transfer, Rotator Cuff Tears, Tendon Transfer Techniques

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • U of Maryland BaltimoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Cuff tear without subscapularis tear-Lower Trapezius group

Cuff tear without subscapularis tear-Latissimus Dorsi group

Cuff tear involving subscapularis tear-Pectoralis group

Cuff tear involving subscapularis tear-Latissimus Dorsi group

Arm Description

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

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

Rotator cuff tears involving the subscapularis muscle repaired using Pectoralis tendon

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 8, 2020
Last Updated
May 13, 2023
Sponsor
University of Maryland, Baltimore
search

1. Study Identification

Unique Protocol Identification Number
NCT04588506
Brief Title
Tendon Transfer Rotator Cuff Tear
Official Title
Tendon Transfer Techniques for Massive Rotator Cuff Tear Repairs: An Integrated Prospective Randomized Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
Massive Rotator Cuff Tears, Tendon Transfer, Rotator Cuff Tears, Tendon Transfer Techniques

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cuff tear without subscapularis tear-Lower Trapezius group
Arm Type
Active Comparator
Arm Description
Rotator cuff tears excluding the subscapularis muscle repaired using Lower Trapezius tendon
Arm Title
Cuff tear without subscapularis tear-Latissimus Dorsi group
Arm Type
Active Comparator
Arm Description
Rotator cuff tears excluding the subscapularis muscle repaired using Latissimus Dorsi tendon
Arm Title
Cuff tear involving subscapularis tear-Pectoralis group
Arm Type
Active Comparator
Arm Description
Rotator cuff tears involving the subscapularis muscle repaired using Pectoralis tendon
Arm Title
Cuff tear involving subscapularis tear-Latissimus Dorsi group
Arm Type
Active Comparator
Arm Description
Rotator cuff tears involving the subscapularis muscle repaired using Latissimus Dorsi tendon
Intervention Type
Procedure
Intervention Name(s)
Lower Trapezius Tendon Transfer Technique
Intervention Description
Lower Trapezius tendon used in repairing cuff tear
Intervention Type
Procedure
Intervention Name(s)
Latissimus Dorsi Tendon Transfer Technique
Intervention Description
Latissimus Dorsi tendon used in repairing cuff tear
Intervention Type
Procedure
Intervention Name(s)
Pectoralis Tendon Transfer Technique
Intervention Description
Pectoralis tendon used in repairing cuff tear
Primary Outcome Measure Information:
Title
12-point difference in American Shoulder and Elbow Surgeon (ASES) scores
Description
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.
Time Frame
At one year post-operative follow-up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashfaq S Hasan, MD
Phone
410-402-0640
Email
ahassan@som.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashfaq S Hasan, MD
Organizational Affiliation
U of Maryland Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
U of Maryland Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashfaq S Hasan, MD
Phone
410-402-0640
First Name & Middle Initial & Last Name & Degree
Ashfaq S Hasan, MD
First Name & Middle Initial & Last Name & Degree
Mohit Gilotra, MD
First Name & Middle Initial & Last Name & Degree
Brian Shiu, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared

Learn more about this trial

Tendon Transfer Rotator Cuff Tear

We'll reach out to this number within 24 hrs