Clinical Trial

MRI Evaluation of Integrity Implant for Rotator Cuff Tears

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated October 20, 2025 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-04-04; most recent amendment 2025-10-16.
Status change: Enrolling by Invitation → Active, Not Recruiting 2025-07-16
Status change: Not Yet Recruiting → Enrolling by Invitation 2024-06-12
Trial Details
NCT Number NCT06353893
Lead Sponsor Foundation for Orthopaedic Research and Education
Collaborators: Anika Therapeutics, Inc.
Conditions Rotator Cuff Tears
Enrollment 20 participants
Start Date 2024-04-01
Primary Completion 2025-12-01 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-10-20