NCT06353893

MRI Evaluation of Integrity Implant for Rotator Cuff Tears

Postoperative MRI Evaluation of the Integrity Bio-inductive Implant Augmentation of Rotator Cuff Tears of the Shoulder

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Foundation for Orthopaedic Research and Education · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
DEVICE	Anika Integrity Implant System	The implant is a porous, flexible construct knitted using HYAFF® fibers and designed to support cell infiltration and regenerative healing. HYAFF is Anika's proven and proprietary esterified HA technology that resorbs over time as tissue remodels. Integrity is inherently strong and can be confidently manipulated arthroscopically, which offers a truly unique and differentiated solution for shoulder surgeons to treat rotator cuff tears.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-12-01
• Completion: 2026-05-01
• First posted: 2024-04-09
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study