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NCT04450342 · ClinicalTrials.gov registry record · NA
REGENETEN™ Bioinductive Implant System in Full-thickness Tears
A NA study, sponsored by Smith & Nephew.
- Terminated
- Registry status
- NA
- Development phase
- 119
- Enrollment target
NCT04450342: Clinical Trial NA study, sponsored by Smith & Nephew.
NCT04450342 is a NA study that was terminated before completion, run by Smith & Nephew. The registered enrollment target is 119 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04450342, a NA study, was terminated before completion, sponsored by Smith & Nephew.
- TERMINATED
- Registry status
- NA
- Development phase
- 119 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Retear rate was measured by the percentage of retears 6 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
Interventions
- PROCEDURE Arthroscopic rotator cuff repair
- DEVICE Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation
- DEVICE Arthroscopic rotator cuff repair for revision surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2020-12-07 |
| Est. Completion | 2023-10-31 |
| Phase | NA |
Why NCT04450342 stopped before completion
NCT04450342 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Arthroscopic rotator cuff repair is the first listed.
NCT04450342 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04450342 about?
NCT04450342 is a clinical study titled "REGENETEN™ Bioinductive Implant System in Full-thickness Tears". 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.
What is the current status of trial NCT04450342?
This trial is currently terminated. It is a NA study. The enrollment target is 119 participants. The study started on 2020-12-07. Estimated completion is 2023-10-31.
What interventions are being tested in trial NCT04450342?
The interventions under investigation include: Arthroscopic rotator cuff repair (PROCEDURE), Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation (DEVICE), Arthroscopic rotator cuff repair for revision surgery (DEVICE).
Who is sponsoring clinical trial NCT04450342?
This trial is sponsored by Smith & Nephew, which has 72 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04450342's enrollment target sits among peer trials
119 803rd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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