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

NARecruitingINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

June 14, 2023

Primary Completion Date

August 1, 2026

Study Completion Date

August 1, 2026

Conditions

Rotator Cuff Tears

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

Trial Locations (1)

RECRUITING

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors

collaborator

Skye Biologics Holdings, LLC

INDUSTRY

lead

The University of Texas Health Science Center, Houston

OTHER