Integrity Implant System Post Market Clinical Follow-Up Study

Description

The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair).

Conditions

Rotator Cuff Tears of the Shoulder

Study Overview

Study Details

Study overview

The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair).

Post Market Confirmatory Interventional Clinical Study of the Integrity Implant System Used for Rotator Cuff Tear Augmentation

Integrity Implant System Post Market Clinical Follow-Up Study

Condition
Rotator Cuff Tears of the Shoulder
Intervention / Treatment

-

Contacts and Locations

Tampa

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

Fishers

Central Indiana Orthopaedics, Fishers, Indiana, United States, 46037

Louisville

Norton Healthcare, Louisville, Kentucky, United States, 40202

Towson

Towson Orthopaedic Associates/University of Maryland St. Joseph's Medical Center, Towson, Maryland, United States, 21204

Marlton

Virtua Health, Marlton, New Jersey, United States, 08053

Greenville

Steadman Hawkins Clinic of the Carolinas, Greenville, South Carolina, United States, 29615

Germantown

Campbell Clinic, Germantown, Tennessee, United States, 38138

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Anika Therapeutics, Inc.,

    Study Record Dates

    2027-10