RECRUITING

Integrity Implant System Post Market Clinical Follow-Up Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2025-02-01
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06741527

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Kara Mezger
CONTACT
7657710026
kmezger@anika.com
Supraja Kotharu
CONTACT
781-457-9000
skotharu@anika.com

Study Locations (Sites)

Foundation for Orthopaedic Research and Education
Tampa, Florida, 33607
United States
Central Indiana Orthopaedics
Fishers, Indiana, 46037
United States
Norton Healthcare
Louisville, Kentucky, 40202
United States
Towson Orthopaedic Associates/University of Maryland St. Joseph's Medical Center
Towson, Maryland, 21204
United States
Virtua Health
Marlton, New Jersey, 08053
United States
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, 29615
United States
Campbell Clinic
Germantown, Tennessee, 38138
United States

Collaborators and Investigators

Sponsor: 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 Registration Dates

Study Start Date2025-02-01
Study Completion Date2027-10

Study Record Updates

Study Start Date2025-02-01
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • Rotator Cuff Repair
  • Shoulder repair
  • Integrity Implant

Additional Relevant MeSH Terms

  • Rotator Cuff Tears of the Shoulder