MRI Evaluation of Integrity Implant for Rotator Cuff Tears

September 8, 2026 updated by: Foundation for Orthopaedic Research and Education

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MRI Assessment of Adverse Events and Structural Integrity
Time Frame: 3 and 6 months after index procedure
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effectiveness Evaluation with PROMIS outcome tool
Time Frame: 3 months after index procedure
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
Time Frame: 6 months after index procedure
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
Time Frame: 3 months after index procedure
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
Time Frame: 6 months after index procedure
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
Time Frame: 3 months after index procedure
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
Time Frame: 6 months after index procedure
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foundation for Orthopaedic Research and Education

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Anika Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 23, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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