Integrity Implant System Post Market Clinical Follow-Up Study

Recruiting now · Not applicable

Conditions studied: Rotator Cuff Tears of the Shoulder

In brief

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).

Key facts

Study ID

NCT06741527

Run by

Anika Therapeutics, Inc.

People needed

150

Starts

2025-02-01

Expected to finish

2027-10-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• The subject exclusion criteria are as follows:
• Medical condition that in the PI's opinion would place the subject at risk or interfere with the study
• Vulnerable population (prisoners, minors, pregnant women, mentally ill persons and the elderly or any person under any undue pressure from others to participate in the study)
• Pregnant, breastfeeding, or plans to become pregnant during the study
• History of poor compliance with medical treatment of any kind
• Deemed contraindicated for MRI by the PI
• Previous rotator cuff surgery (any type) on the index shoulder
• Current instability of the index shoulder
• Rotator cuff tendon tear is a Massive Cofield Classified Full-Thickness Tear (tear length >5cm)
• Chondromalacia of index shoulder ≥ Grade 3
• Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
• Insulin dependent Type I Diabetes
• History of heavy smoking (≥ 1 pack per day) within last 6-months
• History of auto-immune or immunodeficiency disorders
• Currently taking immunosuppression medication for other diseases (e.g., transplants or other inflammatory diseases)
• Oral steroid use in the last 2-months or injectable steroid use in the last 3-months
• History of cognitive or mental health status that interferes with study participation
• Poor comprehension of English language
• Meets one or more of the contraindications defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include:
• 1 Rotator cuff tendon tear is deemed irreparable by the PI
• 2 Rotator cuff tendon tear repair requires replacement of damaged tendon
• 3 Rotator cuff tendon tear repair requires fixation of soft tissue to adjoining soft tissue
• 4 Rotator cuff tendon tear repair requires tendon strength reinforcement
• 5 Presence of infection
• 6 Any condition which would limit the ability or willingness to restrict activities or follow directions during the healing period

Where it is running

• OrthoArizona — Gilbert, Arizona, United States (enrolling)
• Premier Orthopaedic Trauma Specialists, PMC — Pomona, California, United States (enrolling)
• Foundation for Orthopaedic Research and Education — Tampa, Florida, United States (enrolling)
• Harbin Clinic — Rome, Georgia, United States (enrolling)
• Central Indiana Orthopaedics — Fishers, Indiana, United States (enrolling)
• Towson Orthopaedic Associates/University of Maryland St. Joseph's Medical Center — Towson, Maryland, United States (enrolling)
• Virtua Health — Marlton, New Jersey, United States (enrolling)
• Steadman Hawkins Clinic of the Carolinas — Greenville, South Carolina, United States (enrolling)
• Campbell Clinic — Germantown, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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