Tendon Transfer Techniques for Rotator Cuff Tears
Trial Summary
What is the purpose of this 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. 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment Latissimus Dorsi Tendon Transfer Technique for rotator cuff tears?
Is tendon transfer surgery for rotator cuff tears safe?
How is the tendon transfer treatment for rotator cuff tears different from other treatments?
Tendon transfer techniques for rotator cuff tears, such as the Latissimus Dorsi, Lower Trapezius, and Pectoralis Major transfers, are unique because they involve moving a tendon from one part of the body to another to restore shoulder function when the rotator cuff is irreparable. These techniques are often used after other surgeries have failed and are tailored to address specific deficits in shoulder movement, such as loss of elevation or rotation.3591011
Research Team
Ashfaq S Hasan, MD
Principal Investigator
U of Maryland Baltimore
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo tendon transfer surgery using either Latissimus Dorsi, Lower Trapezius, or Pectoralis techniques
Follow-up
Participants are monitored for post-surgical outcomes and compared between treatment groups
Treatment Details
Interventions
- Latissimus Dorsi Tendon Transfer Technique
- Lower Trapezius Tendon Transfer Technique
- Pectoralis Tendon Transfer Technique
Latissimus Dorsi Tendon Transfer Technique is already approved in United States, European Union, Canada for the following indications:
- Irreparable rotator cuff tears involving the supraspinatus and infraspinatus tendons
- Massive rotator cuff tears involving the supraspinatus and infraspinatus tendons
- Posterosuperior irreparable rotator cuff tears
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor