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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT05894265
Status
Recruiting
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Conditions

  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jun 14, 2023
Status verified
Apr 2026
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ActiveMatrix® Dosage A
  • Experimental: ActiveMatrix® Dosage B
  • Placebo Comparator: Saline Injection

Primary Outcome Measure

Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI) [ Time Frame: 6 months post surgery , 12 months post surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Eric F Berkman, MD
[email protected]
713-314-4112
Layla Haidar
[email protected]
713-486-5529

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By research site
The University of Texas Health Science Center at Houston· Houston, TX

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