Actively Recruiting
Prospective Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft Active Matrix (AM) vs. Standard of Care in Arthroscopic Rotator Cuff Repair
Led by The University of Texas Health Science Center, Houston · Updated on 2026-04-29
72
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
S
Skye Biologics Holdings, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair surgery
CONDITIONS
Official Title
Prospective Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft Active Matrix (AM) vs. Standard of Care in Arthroscopic Rotator Cuff Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Willingness to follow all study procedures and be available for the study duration
- Have 1-2 full thickness reparable rotator cuff tendon tears
- Definition of reparable tear: tendon can be moved back to the bone under minimal tension
- Definition of full thickness tear: mostly supraspinatus and less than half infraspinatus involved with no significant subscapularis tear
- Failed 4-6 weeks of physical therapy or guided home exercises and activity modification
- No allergies or contraindications to the treatment
- Have current shoulder imaging (X-rays and MRI) to exclude other causes
- Able and willing to follow post-operative physical therapy and study follow-up
You will not qualify if you...
- Prior surgery on the affected shoulder within 12 months, including Latarjet, SLAP repair, or failed rotator cuff surgery
- Prior bone defect surgery requiring implantation on the affected shoulder
- Steroid injection in the affected shoulder within 6 weeks
- Subscapularis tear involving more than one-third of the tendon needing repair
- Calcific tendonitis in the affected shoulder
- Fatty infiltration of rotator cuff muscles classified as Grade 3 or higher
- Injury to the opposite shoulder that could affect rehabilitation
- Advanced osteoarthritis of the shoulder joint (Grade 2 or higher)
- History of cancer or bone metastases
- History of abnormal bone growth (heterotopic ossification)
- Chronic pain disorders such as fibromyalgia
- Current substance abuse as judged by the investigator
- For women of childbearing potential: unable/unwilling to use contraception, pregnant, breastfeeding, or planning pregnancy during the study
- Currently or recently (within 30 days) enrolled in another similar study
- Involved in injury litigation or workers compensation claims
- Any condition the investigator believes would interfere with participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Eric F Berkman, MD
CONTACT
L
Layla Haidar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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