MRI Evaluation of Integrity Implant for Rotator Cuff Tears

Foundation for Orthopaedic Research and Education

Status: Active, not recruiting

Conditions: Rotator Cuff Tears

Treatments: Device: Anika Integrity Implant System

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06353893

Integrity-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.