MRI Evaluation of Integrity Implant for Rotator Cuff Tears (NCT06353893)
Postoperative MRI Evaluation of the Integrity Bio-inductive Implant Augmentation of Rotator Cuff Tears of the Shoulder
🩺 Plain-English Summary (8th-Grade Level)
The goal of this observational study is to evaluate the effectiveness and safety of the Integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. The main questions it aims to answer are: * How does the application of the Integrity implant affect patient-reported outcome measures (PROMs) such as ASES, SANE, and PROMIS? * What are the imaging characteristics of the rotator cuff tears at 3 and 6 months postoperatively when using the Integrity implant? Postoperative MRIs will be obtained from 10 consecutive patients who have undergone rotator cuff repair using the Integrity implant at 3 and 6 months after surgery. Participants include those with partial and full thickness tears treated with different surgical techniques involving the implant. They may receive either isolated onlay use of the graft for partial tears or augmentation of a standard single or double row repair with the graft applied to the superior surface of the repair.
Who can join: Review the eligibility criteria below.
Location: Foundation for Orthopaedic Research and Education — Tampa, Florida
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Foundation for Orthopaedic Research and Education — Tampa, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Rotator Cuff Tears
- E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults — New York, New York
- Variation in Humeral Head Bone Marrow Characteristics With Rotator Cuff Repair Healing — Cleveland, Ohio
- Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease — Great Neck, New York
- Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study — San Francisco, California
- Maximal Repair Versus Bridging Reconstruction with BioBrace® — Halifax, Nova Scotia
Explore by condition: All Rotator Cuff Tears clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.