MRI Evaluation of Integrity Bio-Inductive Implant for Rotator Cuff Tears

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial Description

The aim of this prospective, non-randomized, open-label, single-arm study is to evaluate the safety and effectiveness of the newly FDA-cleared Integrity graft for various types of rotator cuff repairs. This study incorporates preoperative assessments as well as follow-up assessments at 3 months and 6 months postoperatively. The primary objective is to document the safety profile of the Integrity graft by monitoring device-related adverse events throughout the study duration. Additionally, the study aims to assess the post-market effectiveness of the Integrity implant using patient-reported outcome measures and establish normal or standard findings on MRI to aid surgeons in clinical decision-making. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06353893
Study type	Observational
Source	Foundation for Orthopaedic Research and Education
Contact
Status	Enrolling by invitation
Phase
Start date	April 1, 2024
Completion date	May 1, 2026

View Details

See also
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