Prospective Pilot Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (Active Matrix) vs. Standard of Care in Arthroscopic Rotator Cuff Repair
The University of Texas Health Science Center, Houston
Summary
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
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 invo…
Interventions
- OtherActiveMatrix® Dosage A
This group will receive ActiveMatrix® (AM) product dosage A (1cc AM diluted to 3cc with saline)
- OtherActiveMatrix® Dosage B
Group 2 will receive ActiveMatrix® product dosage B (2cc AM diluted to 3cc with saline)
- ProcedureSaline injection
Group 3 will receive saline injection
Location
- The University of Texas Health Science Center at HoustonHouston, Texas