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NCT03985839 · ClinicalTrials.gov registry record
Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip
A clinical trial, sponsored by Smith & Nephew.
- Completed
- Registry status
- 299
- Enrollment target
NCT03985839: Completed study, sponsored by Smith & Nephew.
NCT03985839 is a clinical trial that has completed, run by Smith & Nephew. The registered enrollment target is 299 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03985839 has completed, sponsored by Smith & Nephew.
- COMPLETED
- Registry status
- 299 participants
- Enrollment target
Study Summary
This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors implanted in 300 subjects needing reattachment of soft tissue to bone.
Primary Outcome
Repair failure at 6 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain). In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss. The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the
Interventions
- DEVICE MICRORAPTOR™ REGENESORB™ Suture Anchor
- DEVICE MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor
- DEVICE MICRORAPTOR™ Knotless PEEK Suture Anchor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2024-08-08 |
What the finished NCT03985839 record still lists
NCT03985839 is an observational study that tracks outcomes without assigning an intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which MICRORAPTOR™ REGENESORB™ Suture Anchor is the first listed.
NCT03985839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03985839 about?
NCT03985839 is a clinical study titled "Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip". This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors implanted in 300 subjects needing reattachment of soft tissue to bone.
What is the current status of trial NCT03985839?
This trial is currently completed. The enrollment target is 299 participants. The study started on 2019-08-01. Estimated completion is 2024-08-08.
What interventions are being tested in trial NCT03985839?
The interventions under investigation include: MICRORAPTOR™ REGENESORB™ Suture Anchor (DEVICE), MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor (DEVICE), MICRORAPTOR™ Knotless PEEK Suture Anchor (DEVICE).
Who is sponsoring clinical trial NCT03985839?
This trial is sponsored by Smith & Nephew, which has 72 total clinical trials registered on ClinicalTrials.gov.
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