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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-04-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Skye Biologics Holdings, LLC

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Eric F Berkman, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-14
Primary Completion
2026-08-01
Completion
2026-08-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05894265 on ClinicalTrials.gov