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NCT06353893 · ClinicalTrials.gov registry record
MRI Evaluation of Integrity Implant for Rotator Cuff Tears
A clinical trial of Rotator Cuff Tears, sponsored by Foundation for Orthopaedic Research and Education.
- Active
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT06353893: Active study of Rotator Cuff Tears, sponsored by Foundation for Orthopaedic Research and Education.
NCT06353893 is a study of Rotator Cuff Tears that is active but no longer recruiting, run by Foundation for Orthopaedic Research and Education. The registered enrollment target is 20 participants, below the 1,280-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06353893, a study of Rotator Cuff Tears, is active but no longer recruiting, sponsored by Foundation for Orthopaedic Research and Education.
- ACTIVE NOT RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this observational study is to evaluate the effectiveness and safety of the Integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. The main questions it aims to answer are: * How does the application of the Integrity implant affect patient-reported outcome measures (PROMs) such as ASES, SANE, and PROMIS? * What are the imaging characteristics of the rotator cuff tears at 3 and 6 months postoperatively when using the Integrity implant? Postoperative MRIs will be obtained from 10 consecutive patients who have undergone rotator cuff repair using the Integrity implant at 3 and 6 months after surgery. Participants include those with partial and full thickness tears treated with different surgical techniques involving the implant. They may receive either isolated onlay use of the graft for partial tears or augmentation of a standard single or double row repair with the graft applied to the superior surface of the repair.
Primary Outcome
The primary endpoint of this study is the adverse events rate and structural failure rate of the rotator cuff repair, determined by MRI, at 3 months and 6 months following use of the Anika Integrity implant system.
Conditions Studied
Interventions
- DEVICE Anika Integrity Implant System
Study Locations (1)
Florida
- Foundation for Orthopaedic Research and Education - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2026-05-01 |
What the registry record for NCT06353893 still lists
NCT06353893 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,280-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Rotator Cuff Tears appearing as the primary indexed condition, and to 1 intervention - of which Anika Integrity Implant System is the first listed.
NCT06353893 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06353893 about?
NCT06353893 is a clinical study titled "MRI Evaluation of Integrity Implant for Rotator Cuff Tears". The goal of this observational study is to evaluate the effectiveness and safety of the Integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. The main questions it aims to answer are: * How does the application of the Integrity implant affect patient-reported ou...
What is the current status of trial NCT06353893?
This trial is currently active not recruiting. The enrollment target is 20 participants. The study started on 2024-04-01. Estimated completion is 2026-05-01.
What conditions does trial NCT06353893 study?
This clinical trial studies the following conditions: Rotator Cuff Tears.
What interventions are being tested in trial NCT06353893?
The interventions under investigation include: Anika Integrity Implant System (DEVICE).
Who is sponsoring clinical trial NCT06353893?
This trial is sponsored by Foundation for Orthopaedic Research and Education, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06353893 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Rotator Cuff Tears
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06353893's enrollment target sits among peer trials
20 20th of 20 the lowest of 20 other Rotator Cuff Tears trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rotator Cuff Tears 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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