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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: Completed NA study, sponsored by The Hawkins Foundation.
NCT02350647 is a NA study that has completed, run by The Hawkins Foundation. The registered enrollment target is 64 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The ossification quality score is an ordinal measure of quality of bone reabsorption that is divided into four progressive groups. Quality score 1 reflects "little or no bone ossification", Quality score 2 reflects "Some ossification; discontinuous or with a wide lucent rim", Quality score 3 reflects "Ossification with a thin lucent rim", and Quality score 4 reflects "Good ossification; border of tract vague". For this study, Quality scores 1 and 2 will be merged (defined as low quality ossifica
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 |
What the finished NCT02350647 record still lists
NCT02350647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Suture Anchor HEALOCOIL is the first listed.
NCT02350647 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02350647's enrollment target sits among peer trials
64 1147th of 2000 higher than 844 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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