MRI Evaluation of Integrity Implant for Rotator Cuff Tears

NCT06353893 | Active Not Recruiting FDA Device

• 1 other identifier: Integrity-001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• MRI Assessment of Adverse Events and Structural Integrity

  The primary endpoint of this study is the adverse events rate and structural failure rate of the rotator cuff repair, determined by MRI, at 3 months and 6 months following use of the Anika Integrity implant system.

  3 and 6 months after index procedure

Secondary Outcomes (6)

• Effectiveness Evaluation with PROMIS outcome tool

  3 months after index procedure

• Effectiveness Evaluation with PROMIS tool

  6 months after index procedure

• Effectiveness Evaluation with SANE score

  3 months after index procedure

• Effectiveness Evaluation with SANE score

  6 months after index procedure

• Effectiveness Evaluation with ASES rating scale

  3 months after index procedure

Interventions

Anika Integrity Implant System DEVICE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be recruited from patients with a history of rotator cuff repair surgery one to 83 days (about 2 and a half months) before the screening.

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.

Sponsors & Collaborators

• Foundation for Orthopaedic Research and Education: lead
• Anika Therapeutics, Inc.: collaborator

Study Sites (1)

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33607, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 9, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)