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MRI Evaluation of Integrity Implant for Rotator Cuff Tears

NCT06353893 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-10-20

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tears

Interventions

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.

Sponsors & Collaborators

  • Anika Therapeutics, Inc.

    collaborator INDUSTRY

  • Foundation for Orthopaedic Research and Education

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-12-01
Completion
2026-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06353893 on ClinicalTrials.gov