Rotator Cuff TearsNCT04588506
Tendon Transfer Rotator Cuff Tear
A study testing Lower Trapezius Tendon Transfer Technique, Latissimus Dorsi Tendon Transfer Technique and Pectoralis Tendon Transfer Technique in people with Rotator Cuff Tears, run by University of Maryland, Baltimore at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Lower Trapezius Tendon Transfer Technique, Latissimus Dorsi Tendon Transfer Technique and Pectoralis Tendon Transfer Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 11 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Rotator Cuff Tears
- Being tested
- Lower Trapezius Tendon Transfer Technique, Latissimus Dorsi Tendon Transfer Technique, Pectoralis Tendon Transfer Technique
- Keywords
- Massive Rotator Cuff Tears, Tendon Transfer, Rotator Cuff Tears, Tendon Transfer Techniques
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Trapezius Tendon Transfer TechniqueProcedure or surgery
Lower Trapezius tendon used in repairing cuff tear
Latissimus Dorsi Tendon Transfer TechniqueProcedure or surgery
Latissimus Dorsi tendon used in repairing cuff tear
Pectoralis Tendon Transfer TechniqueProcedure or surgery
Pectoralis tendon used in repairing cuff tear
| Study group | Role | What they receive |
|---|---|---|
| Cuff tear without subscapularis tear-Lower Trapezius group | Active comparator | Rotator cuff tears excluding the subscapularis muscle repaired using Lower Trapezius tendon Receives: Procedure: Lower Trapezius Tendon Transfer Technique |
| Cuff tear without subscapularis tear-Latissimus Dorsi group | Active comparator | Rotator cuff tears excluding the subscapularis muscle repaired using Latissimus Dorsi tendon Receives: Procedure: Latissimus Dorsi Tendon Transfer Technique |
| Cuff tear involving subscapularis tear-Pectoralis group | Active comparator | Rotator cuff tears involving the subscapularis muscle repaired using Pectoralis tendon Receives: Procedure: Pectoralis Tendon Transfer Technique |
| Cuff tear involving subscapularis tear-Latissimus Dorsi group | Active comparator | Rotator cuff tears involving the subscapularis muscle repaired using Latissimus Dorsi tendon Receives: Procedure: Latissimus Dorsi Tendon Transfer Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At one year post-operative follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start15 Feb 2022
- Primary completion11 Dec 2024
- Study completion11 Dec 2024
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashfaq Hasan, University of Maryland, Baltimore
- Investigators
- Ashfaq S Hasan, MD, Principal investigator, U of Maryland Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588506
- Sponsor's protocol ID
- HP-00091132
- Status last verified
- Jun 2025
- First submitted
- 8 Oct 2020
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tendon Transfer Techniques for Massive Rotator Cuff Tear Repairs: An Integrated Prospective Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT04588506
- Acronym / sponsor ID
- HP-00091132
- Conditions
- Rotator Cuff Tears
- Keywords
- Massive Rotator Cuff Tears, Tendon Transfer, Rotator Cuff Tears, Tendon Transfer Techniques
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cuff tear without subscapularis tear-Lower Trapezius group | Active comparator | Procedure: Lower Trapezius Tendon Transfer TechniqueRotator cuff tears excluding the subscapularis muscle repaired using Lower Trapezius tendon |
| Cuff tear without subscapularis tear-Latissimus Dorsi group | Active comparator | Procedure: Latissimus Dorsi Tendon Transfer TechniqueRotator cuff tears excluding the subscapularis muscle repaired using Latissimus Dorsi tendon |
| Cuff tear involving subscapularis tear-Pectoralis group | Active comparator | Procedure: Pectoralis Tendon Transfer TechniqueRotator cuff tears involving the subscapularis muscle repaired using Pectoralis tendon |
| Cuff tear involving subscapularis tear-Latissimus Dorsi group | Active comparator | Procedure: Latissimus Dorsi Tendon Transfer TechniqueRotator cuff tears involving the subscapularis muscle repaired using Latissimus Dorsi tendon |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- Subjects having severe glenohumeral arthritis
- History of prior tendon transfer
- Axillary nerve injury
- Deltoid deficiency
- Subjects with pseudo paralysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower Trapezius Tendon Transfer TechniqueLower Trapezius tendon used in repairing cuff tear | Procedure or surgery | Cuff tear without subscapularis tear-Lower Trapezius group |
| Latissimus Dorsi Tendon Transfer TechniqueLatissimus Dorsi tendon used in repairing cuff tear | Procedure or surgery | Cuff tear involving subscapularis tear-Latissimus Dorsi group, Cuff tear without subscapularis tear-Latissimus Dorsi group |
| Pectoralis Tendon Transfer TechniquePectoralis tendon used in repairing cuff tear | Procedure or surgery | Cuff tear involving subscapularis tear-Pectoralis group |
Primary outcome
12-point difference in American Shoulder and Elbow Surgeon (ASES) scores
Time frame: At one year post-operative follow-up visit
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.
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No. No individual participant data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashfaq S Hasan, MD principal investigator
U of Maryland Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower Trapezius Tendon Transfer Technique, Latissimus Dorsi Tendon Transfer Technique and Pectoralis Tendon Transfer Technique in people with Rotator Cuff Tears, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-point difference in American Shoulder and Elbow Surgeon (ASES) scores (time frame: At one year post-operative follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.