REGENETEN™ Bioinductive Implant System in Full-thickness Tears
Public ClinicalTrials.gov record NCT04450342. 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
A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of ARCR Augmented With REGENETEN™ Bioinductive Implant System in Full-thickness Tears (Large or Massive) Repair Versus ARCR Alone
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic rotator cuff repair alone.
Study identification
- NCT ID
- NCT04450342
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 119 participants
Conditions and interventions
Conditions
Interventions
- Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation Device
- Arthroscopic rotator cuff repair Procedure
- Arthroscopic rotator cuff repair for revision surgery Device
Device · Procedure
Eligibility (public fields only)
- Age range
- 40 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
- Dec 7, 2020 (Actual)
- Primary completion
- Oct 31, 2023 (Actual)
- Completion
- Oct 31, 2023 (Actual)
- Last update posted
- May 23, 2025
2020 – 2023
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 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Sinai Hospital | Baltimore | Maryland | 21215 | — |
| Syracuse Orthopedic Specialists | DeWitt | New York | 13214 | — |
| Cleveland Clinic | Cleveland | Ohio | 44125 | — |
| Texas Orthopedic Specialists | Bedford | Texas | 76021-5011 | — |
| Houston Methodist The Woodlands | The Woodlands | Texas | 17201 | — |
| Ashland Memorial Medical Center | Ashland | Wisconsin | 54806 | — |
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 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04450342, 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 May 23, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04450342 live on ClinicalTrials.gov.