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

Detailed criteria

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

Other
ActiveMatrix® Dosage A
This group will receive ActiveMatrix® (AM) product dosage A (1cc AM diluted to 3cc with saline)
Other
ActiveMatrix® Dosage B
Group 2 will receive ActiveMatrix® product dosage B (2cc AM diluted to 3cc with saline)
Procedure
Saline injection
Group 3 will receive saline injection

Location

The University of Texas Health Science Center at Houston
Houston, Texas
Eric.F.Berkman@uth.tmc.edu 713-314-4112

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

Summary

Eligibility

Interventions

Location

Compensation

Run this study?

Details

Conditions