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Integrity Implant System for Rotator Cuff Tears

This study is looking at how well the Integrity Implant System works for people with rotator cuff tears in their shoulder. This system is used to help repair the torn rotator cuff. Researchers want to see if it helps prevent the tear from happening again. You might be able to join if you are at least 18 years old and can understand the study information. The main goal is to see the re-tear rate (how often the tear comes back) after 12 months. The study is currently unclear about its recruitment status.

Study design
This study is a single-arm study, meaning all 150 participants will receive the Integrity Implant System. It is a post-market study, following the device after it's been approved.
What's involved
You would complete Patient Reported Outcome Measure (PROM) questionnaires and have MRI evaluations for your shoulder repair integrity, quality, tendon tissue thickness, and regeneration.
Compensation
Not stated in the trial record.
Follow-up
Your re-tear rate will be measured at 12 months after your surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06741527

Integrity Implant System Post Market Clinical Follow-Up Study

Recruiting
NAAges 18+InterventionalTreatment
Anika Therapeutics, Inc.
~150 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Integrity Implant System

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Re-tear rate after rotator cuff augmentation
Measured over 12 months postoperatively

Conditions

Rotator Cuff Tears of the Shoulder

Explore related trials

Rupture of rotator cuff of shoulder

NCT06741527

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Campbell Clinic

    Germantown, Tennesseestudy coordinator listed

    Recruiting

  • Central Indiana Orthopaedics

    Fishers, Indianastudy coordinator listed

    Recruiting

  • Foundation for Orthopaedic Research and Education

    Tampa, Floridastudy coordinator listed

    Recruiting

  • Harbin Clinic

    Rome, Georgiastudy coordinator listed

    Recruiting

  • OrthoArizona

    Gilbert, Arizonastudy coordinator listed

    Recruiting

  • Premier Orthopaedic Trauma Specialists, PMC

    Pomona, Californiastudy coordinator listed

    Recruiting

  • Steadman Hawkins Clinic of the Carolinas

    Greenville, South Carolinastudy coordinator listed

    Recruiting

  • Towson Orthopaedic Associates/University of Maryland St. Joseph's Medical Center

    Towson, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Kara Mezger
[email protected]
781-457-9000
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Re-tear rate after rotator cuff augmentation12 months postoperatively

    Assessed by MRI evaluation at 12 months post-operatively defined using Sugaya classification system.