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NCT04588506 · ClinicalTrials.gov registry record · NA
Tendon Transfer Rotator Cuff Tear
A NA study, sponsored by University of Maryland, Baltimore.
- Terminated
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT04588506: Clinical Trial NA study, sponsored by University of Maryland, Baltimore.
NCT04588506 is a NA study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04588506, a NA study, was terminated before completion, sponsored by University of Maryland, Baltimore.
- TERMINATED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- PROCEDURE Lower Trapezius Tendon Transfer Technique
- PROCEDURE Latissimus Dorsi Tendon Transfer Technique
- PROCEDURE Pectoralis Tendon Transfer Technique
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-02-15 |
| Est. Completion | 2024-12-11 |
| Phase | NA |
Why NCT04588506 stopped before completion
NCT04588506 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Lower Trapezius Tendon Transfer Technique is the first listed.
NCT04588506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04588506 about?
NCT04588506 is a clinical study titled "Tendon Transfer Rotator Cuff Tear". 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 locatio...
What is the current status of trial NCT04588506?
This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2022-02-15. Estimated completion is 2024-12-11.
What interventions are being tested in trial NCT04588506?
The interventions under investigation include: Lower Trapezius Tendon Transfer Technique (PROCEDURE), Latissimus Dorsi Tendon Transfer Technique (PROCEDURE), Pectoralis Tendon Transfer Technique (PROCEDURE).
Who is sponsoring clinical trial NCT04588506?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04588506's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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