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NCT02350647 · ClinicalTrials.gov registry record · NA
Suture Anchor Comparison in Rotator Cuff Repairs
A NA study, sponsored by The Hawkins Foundation.
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
NCT02350647 is a NA study that has completed, run by The Hawkins Foundation. The registered enrollment target is 64 participants.
The verdict
NCT02350647, a NA study, has completed, sponsored by The Hawkins Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
Study Summary
Patients will be randomized to receive HEALICOIL™ REGENESORB (the study anchor) or TWINFIX Ultra HA, a similar comparative product, for use in the repair of their shoulder injury. They will be asked to complete questionnaires throughout the study and will receive an MRI, CT and multiple ultrasound images. The MRIs and radiographs will be used to assess bony ingrowth at the repair site, and the ultrasound to assess repair success rate of the rotator cuff. The clinical and radiological outcomes will be compared between the study and control groups. It is hypothesized that there will be 85% high quality ossification at anchor site for HEALICOIL REGENESORB and 49.9% high quality ossification for TWINFIX Ultra HA at 24 months.
Interventions
- DEVICE Suture Anchor HEALOCOIL
- DEVICE Suture anchor Twinfix Ultra HA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2014-05 |
| Est. Completion | 2019-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02350647
The ClinicalTrials.gov registry entry for NCT02350647 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Hawkins Foundation, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Suture Anchor HEALOCOIL is the first listed.
NCT02350647 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02350647 about?
NCT02350647 is a clinical study titled "Suture Anchor Comparison in Rotator Cuff Repairs". Patients will be randomized to receive HEALICOIL™ REGENESORB (the study anchor) or TWINFIX Ultra HA, a similar comparative product, for use in the repair of their shoulder injury. They will be asked to complete questionnaires throughout the study and will receive an MRI, CT and multiple ultrasound i...
What is the current status of trial NCT02350647?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2014-05. Estimated completion is 2019-03.
What interventions are being tested in trial NCT02350647?
The interventions under investigation include: Suture Anchor HEALOCOIL (DEVICE), Suture anchor Twinfix Ultra HA (DEVICE).
Who is sponsoring clinical trial NCT02350647?
This trial is sponsored by The Hawkins Foundation, which has 11 total clinical trials registered on ClinicalTrials.gov.
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