Actively Recruiting
Post Market Confirmatory Clinical Study of the Integrity Implant System for Rotator Cuff Tear Augmentation
Led by Anika Therapeutics, Inc. · Updated on 2025-11-13
150
Participants Needed
6
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Integrity Implant System for its performance, safety, and clinical benefits when used to support rotator cuff tear repairs or augmentation. This prospective, multi-center, single-arm, non-randomized post-market clinical follow-up study focuses on confirming that the implant helps prevent rotator cuff re-tears and improves shoulder function using standard scoring systems. Participants will receive the Integrity Implant System during surgery for rotator cuff tear augmentation or repair. The implant is applied using mini-open or arthroscopic surgical methods, with fixation achieved by Integrity Tissue Tack and Integrity Bone Staple devices. Treatment outcomes will be monitored over time, including a 12-month postoperative MRI to assess re-tear rates, followed by evaluations up to 24 months. During the study, participants will complete functional assessments such as the American Shoulder and Elbow Surgeons Shoulder Score, Constant-Murley Score, Patient Satisfaction surveys, EuroQol EQ-5D-5L, Single Assessment Numeric Evaluation, and Visual Analogue Scale. MRI scans will measure repair integrity, tendon quality, thickness, and regeneration. Adverse events will be tracked to assess safety, and participants will be followed for two years after surgery to monitor long-term outcomes.
CONDITIONS
Brief 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
- Able to understand study requirements and attend all follow-up visits
- Able to follow post-operative rehabilitation instructions
- Rotator cuff tendon tear surgery performed by mini-open or arthroscopic methods
- Meets intended use criteria for the Integrity Implant System as applied to rotator cuff tears, including suitable tendon tissue and fixation conditions
You will not qualify if you...
- Medical conditions posing risk or interfering with study participation
- Vulnerable populations such as prisoners, minors, pregnant women, mentally ill persons, elderly under pressure
- Pregnant, breastfeeding, or planning pregnancy during the study
- History of poor compliance with medical treatments
- Contraindicated for MRI
- Previous rotator cuff surgery on the same shoulder
- Current instability of the affected shoulder
- Massive full-thickness rotator cuff tear larger than 5 cm
- Severe chondromalacia (Grade 3 or higher) of the shoulder
- Fatty infiltration of rotator cuff muscle (Grade 3 or higher)
- Insulin dependent Type I Diabetes
- Heavy smoking history (one pack or more per day in last 6 months)
- Autoimmune or immunodeficiency disorders
- Current immunosuppression medication use
- Recent oral or injectable steroid use
- Cognitive or mental health issues interfering with participation
- Poor English comprehension
- Contraindications per Integrity Implant System instructions including irreparable tears, infection, hypersensitivity, or inadequate tissue or bone quality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus immediate recovery period
Participants undergo rotator cuff tendon tear surgery with the Integrity Implant System used for augmentation.
1 surgical visit (in-person)
Duration - Up to 24 months postoperatively
Participants are monitored for safety and clinical benefit after surgery. Functional outcomes and repair integrity are assessed through visits and imaging.
Visits at 6 weeks, 6 months, 12 months, and 24 months postoperatively
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
J
Jennifer Williams
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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