Trials / Recruiting
RecruitingNCT05894265
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
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- The University of Texas Health Science Center, Houston · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-06-14
- Primary completion
- 2026-08-01
- Completion
- 2026-08-01
- First posted
- 2023-06-08
- Last updated
- 2025-07-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05894265. Inclusion in this directory is not an endorsement.