MRI Evaluation of Integrity Implant for Rotator Cuff Tears

Running, not enrolling

Conditions studied: Rotator Cuff Tears

In brief

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.

Key facts

Study ID

NCT06353893

Run by

Foundation for Orthopaedic Research and Education

People needed

20

Starts

2024-04-01

Expected to finish

2026-05-01

Last updated by the study team

2025-10-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Rotator cuff tear (both partial and full thickness) treated with Integrity bio-inductive implant augmentation to the superior surface of partial rotator cuff tears or the superior aspect of rotator cuff repairs (both single or double row);
• Subject can read and understand the ICF and has voluntarily provided written informed consent.

You may not qualify if…

• Conditions which, in the opinion of the Principal Investigator, may limit the subject's ability or willingness to follow post- operative care or study instructions;
• If patient is pregnant;
• Subject conditions which may hinder the healing process;
• Subject is a prisoner or member of another vulnerable population.

Where it is running

• Foundation for Orthopaedic Research and Education — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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