Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
Public ClinicalTrials.gov record NCT05444465. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluation of Safety and Efficacy of a Resorbable Collagen Implant in Treatment of High Grade PArtial ThiCkness Tears; A Prospective, Multicenter, Randomized, Control Trial (IMPACT Study)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.
Study identification
- NCT ID
- NCT05444465
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 234 participants
Conditions and interventions
Conditions
Interventions
- Isolated Bioinductive Repair Device
- Completion and Repair Procedure
Device · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 29, 2022
- Primary completion
- Aug 14, 2026
- Completion
- Jun 29, 2028
- Last update posted
- Aug 4, 2026
2022 – 2028
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harbin Clinic | Rome | Georgia | 30165 | Recruiting |
| OrthoIllinois LTD | Rockford | Illinois | 61107 | Recruiting |
| Sinai Hospital Baltimore | Baltimore | Maryland | 21215 | Withdrawn |
| Cleveland Clinic - Sports Health | Garfield Heights | Ohio | 44125 | Withdrawn |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | Recruiting |
| Texas Orthopedic Specialists | Bedford | Texas | 76021 | Active, not recruiting |
| Houston Methodist The Woodlands | The Woodlands | Texas | 77385 | Withdrawn |
| Memorial Medical Center | Ashland | Wisconsin | 54806 | Withdrawn |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05444465, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 4, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05444465 live on ClinicalTrials.gov.