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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Device: Anika Integrity Implant System

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33607
      • Foundation for Orthopaedic Research and Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness Evaluation with PROMIS outcome tool	The secondary endpoints of the study include evaluating PROMIS scores (assessing various aspects of quality of life in a questionnaire which is scored)	3 months after index procedure
Effectiveness Evaluation with PROMIS tool	The secondary endpoints of the study include evaluating PROMIS scores (assessing various aspects of quality of life)	6 months after index procedure
Effectiveness Evaluation with SANE score	The secondary endpoints of the study include evaluating SANE scores: Single assessment numeric rating scale of 0-10 with 0 being NO pain and 10 being worst or severe pain (patients' perceived improvement)	3 months after index procedure
Effectiveness Evaluation with SANE score	The secondary endpoints of the study include evaluating SANE scores: Single assessment numeric rating scale of 0-10 with 0 being NO pain and 10 being worst or severe pain (patients' perceived improvement)	6 months after index procedure
Effectiveness Evaluation with ASES rating scale	The secondary endpoints of the study include evaluating ASES rating scale (for shoulder function and pain) ASES is a mixed-outcome reporting tool, meaning it consists of a physician-rated and patient-rated questionnaire. The patient-rated questionnaire focuses on joint pain, instability and activities of daily living.	3 months after index procedure
Effectiveness Evaluation with ASES rating scale	The secondary endpoints of the study include evaluating ASES rating scale (for shoulder function and pain)ASES is a mixed-outcome reporting tool, meaning it consists of a physician-rated and patient-rated questionnaire. The patient-rated questionnaire focuses on joint pain, instability and activities of daily living.	6 months after index procedure

Collaborators and Investigators

• Sponsor: Foundation for Orthopaedic Research and Education
• Collaborators: Anika Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: Integrity-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes