Actively Recruiting
Integrity Implant System Post Market Clinical Follow-Up Study
Led by Anika Therapeutics, Inc. · Updated on 2025-11-13
150
Participants Needed
6
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Integrity Implant System Post Market Clinical Follow-Up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Able to understand and provide informed consent
- Able to complete all Patient Reported Outcome Measure questionnaires
- Understands study requirements and able to attend all follow-up visits and assessments
- Able to follow all post-operative rehabilitation instructions
- Rotator cuff tendon tear surgery performed by mini-open, single-portal arthroscopic, or multi-portal arthroscopic intervention
- Meets intended use and indications for the Integrity Implant System for rotator cuff tendon tears, including tendon tear management and fixation with Integrity Tissue Tack and Bone Staple
You will not qualify if you...
- Medical condition that places the subject at risk or interferes with the study
- Vulnerable populations such as prisoners, minors, pregnant women, mentally ill persons, elderly, or persons under undue pressure
- Pregnant, breastfeeding, or planning pregnancy during the study
- History of poor compliance with medical treatment
- Contraindication for MRI
- Previous rotator cuff surgery on the index shoulder
- Current instability of the index shoulder
- Massive Cofield Classified Full-Thickness Tear (tear length >5cm)
- Chondromalacia of index shoulder Grade 3 or higher
- Fatty infiltration of rotator cuff muscle Grade 3 or higher
- Insulin-dependent Type I Diabetes
- Heavy smoking history (≥ 1 pack per day) within last 6 months
- Auto-immune or immunodeficiency disorders
- Taking immunosuppression medication for other diseases
- Oral steroid use in last 2 months or injectable steroid use in last 3 months
- Cognitive or mental health issues interfering with participation
- Poor comprehension of English language
- Contraindications defined within the Integrity Implant System IFUs, including irreparable tendon tear, repair requiring tendon replacement or soft tissue fixation, infection, limited ability to follow healing instructions, hypersensitivity to implant components, inadequate tissue or bone quality for fixation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Foundation for Orthopaedic Research and Education
Tampa, Florida, United States, 33607
Actively Recruiting
2
Central Indiana Orthopaedics
Fishers, Indiana, United States, 46037
Actively Recruiting
3
Towson Orthopaedic Associates/University of Maryland St. Joseph's Medical Center
Towson, Maryland, United States, 21204
Actively Recruiting
4
Virtua Health
Marlton, New Jersey, United States, 08053
Actively Recruiting
5
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, United States, 29615
Actively Recruiting
6
Campbell Clinic
Germantown, Tennessee, United States, 38138
Actively Recruiting
Research Team
K
Kara Mezger
CONTACT
J
Jennifer Williams
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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