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Procedure

Tendon Transfer Techniques for Rotator Cuff Tears

N/A
Recruiting
Led By Ashfaq S Hasan, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects between 18 years and 65 years (≥ 18 and ≤ 65 years of age)
Subjects must have massive, irreparable tear of the posterior-superior rotator cuff
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at one year post-operative follow-up visit
Awards & highlights

Study Summary

This trial is comparing 3 different techniques for repairing large tears in muscles around the shoulder. There are currently no studies to show which technique has better outcomes.

Who is the study for?
This trial is for adults aged 18-65 with massive, irreparable rotator cuff tears and minimal shoulder arthritis. It's not for those with axillary nerve injury, deltoid deficiency, pseudo paralysis, severe shoulder arthritis, a history of tendon transfer or deep infection after surgery.Check my eligibility
What is being tested?
The study compares three muscle tendon transfer techniques to repair large shoulder muscle tears: using tendons from the lower back (Latissimus Dorsi), upper back (Lower Trapezius), or chest (Pectoralis). Outcomes of two different pairings will be evaluated over two years.See study design
What are the potential side effects?
Potential side effects may include pain at the donor or surgical site, weakness in transferred muscles, reduced range of motion in the shoulder joint, and complications related to surgery such as infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have a severe, unfixable tear in my shoulder's rotator cuff.
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My shoulder tendon tear cannot be repaired.
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My shoulder arthritis is minimal or not present.
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My shoulder tendon tear cannot be repaired.
Select...
I have a severe, unfixable tear in my shoulder's rotator cuff.
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at one year post-operative follow-up visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and at one year post-operative follow-up visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
12-point difference in American Shoulder and Elbow Surgeon (ASES) scores

Trial Design

4Treatment groups
Active Control
Group I: Cuff tear without subscapularis tear-Lower Trapezius groupActive Control1 Intervention
Rotator cuff tears excluding the subscapularis muscle repaired using Lower Trapezius tendon
Group II: Cuff tear without subscapularis tear-Latissimus Dorsi groupActive Control1 Intervention
Rotator cuff tears excluding the subscapularis muscle repaired using Latissimus Dorsi tendon
Group III: Cuff tear involving subscapularis tear-Latissimus Dorsi groupActive Control1 Intervention
Rotator cuff tears involving the subscapularis muscle repaired using Latissimus Dorsi tendon
Group IV: Cuff tear involving subscapularis tear-Pectoralis groupActive Control1 Intervention
Rotator cuff tears involving the subscapularis muscle repaired using Pectoralis tendon

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
685 Previous Clinical Trials
372,962 Total Patients Enrolled
Ashfaq S Hasan, MDPrincipal InvestigatorU of Maryland Baltimore

Media Library

Latissimus Dorsi Tendon Transfer Technique (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04588506 — N/A
Rotator Cuff Tears Research Study Groups: Cuff tear without subscapularis tear-Lower Trapezius group, Cuff tear without subscapularis tear-Latissimus Dorsi group, Cuff tear involving subscapularis tear-Latissimus Dorsi group, Cuff tear involving subscapularis tear-Pectoralis group
Rotator Cuff Tears Clinical Trial 2023: Latissimus Dorsi Tendon Transfer Technique Highlights & Side Effects. Trial Name: NCT04588506 — N/A
Latissimus Dorsi Tendon Transfer Technique (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04588506 — N/A
Rotator Cuff Tears Patient Testimony for trial: Trial Name: NCT04588506 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the enrollment process for this clinical trial been initiated?

"Clinicaltrials.gov confirms that enrolment for this clinical trial is currently taking place. It was initially posted on February 15th 2022, and last revised on March 25th 2022."

Answered by AI

What is the current participant capacity of this research endeavor?

"Affirmative. Evidenced by the information posted on clinicaltrials.gov, this medical trial is actively seeking candidates. This study was first introduced to the public on February 15th 2022 and most recently updated on March 25th 2022; in total 84 patients will be recruited from one location for participation."

Answered by AI

Does the protocol of this experiment extend to include individuals aged eighty-five or above?

"The age parameters established for enrollment into this clinical trial are between 18 and 65, with 10 trials available to those under the legal adult age, and 94 options available for seniors."

Answered by AI

Are there any restrictions to taking part in this clinical experiment?

"Eligibility for this clinical trial requires rotator cuff tears as well as an age between 18 and 65. A maximum of 84 patients will be recruited in total."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
District of Columbia
Maryland
How old are they?
18 - 65
What site did they apply to?
U of Maryland Baltimore
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Tore my rotator cuff out curling 280 lbs 10 years ago, it's never been right, it never heals, and over and over I re-tear it all over again, please let me try this procedure.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Any idea how long the wait time is?
PatientReceived no prior treatments
~3 spots leftby Apr 2024