Who is eligible for clinical trial NCT05894265?

Participants must meet protocol criteria for Rotator Cuff Tears. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05894265 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-27

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 (NCT05894265)

🟢 Recruiting Observational / Diagnostic 🩺 Clinical Procedure Protocol Sponsor: The University of Texas Health Science Center, Houston

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (17 items).

Location: The University of Texas Health Science Center at Houston — Houston, Texas

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
1-2 tendon full thickness reparable rotator cuff tendon tear(s) Reparable tear defined as: a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension. Full-thickness tear defined as: a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border
Failed conservative medical management of the rotator cuff tendon tear defined as: 4-6 weeks of formal physical therapy or guided home exercises and activity modification
Have no contraindications or allergies to the treatment administered
Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses
Able and willing to comply with the post-operative physical therapy and study follow-up schedule

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Prior surgery on the index shoulder within 12 months of enrollment, including Latarjet procedures, superior labral treat from anterior to posterior (SLAP), and (failed) primary rotator cuff surgery,
Prior surgery for bone defects requiring bone implantation in the index shoulder,
Steroid injection into the index shoulder within 6 weeks of enrollment.
Subscapularis tear greater than 1/3 of tendon involvement requiring repair,
Calcific tendonitis in the index shoulder,
Fatty infiltration of the index shoulder rotator cuff muscle, i.e. Goutallier classification ≥ Grade 3,
Contralateral shoulder injury that may interfere with the post-operative rotator cuff repair rehab guidelines,
History of advanced osteoarthritis of glenohumeral joint (AC joint can have advanced OA) i.e. Samilson-Prieto classification ≥ Grade 2
History of malignant tumor and osseous metastatic disease,
History of heterotopic ossification,
History of chronic pain disorders (i.e., fibromyalgia),

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

The University of Texas Health Science Center at Houston — Houston, Texas

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗