Follow-up on the Integrity Implant System for shoulder rotator cuff tears
Post Market Confirmatory Interventional Clinical Study of the Integrity Implant System Used for Rotator Cuff Tear Augmentation
This study is testing whether the Integrity Implant System can help people with rotator cuff tears heal better and avoid re-injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Anika Therapeutics, Inc. Industry-sponsored |
| Locations | 6 sites (Tampa, Florida and 5 other locations) |
| Trial ID | NCT06741527 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, multi-center, single-arm, non-randomized clinical follow-up to evaluate the performance, safety, and clinical benefits of the Integrity Implant System used for augmenting rotator cuff tears, with or without repair. It aims to confirm the effectiveness of the implant by monitoring re-tear rates through MRI and assessing functional outcomes using various standardized scoring systems. Safety will be evaluated by tracking adverse events throughout the study period. Participants will undergo assessments at multiple follow-up visits to ensure comprehensive data collection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a rotator cuff tendon tear requiring surgical intervention.
Not a fit: Patients with significant tendon loss or those unable to comply with post-operative rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with rotator cuff tears, potentially reducing re-tear rates and enhancing recovery.
How similar studies have performed: Previous studies on similar implant systems have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
1. At least 18 years of age 2. Able (with assistance from LAR, if necessary) to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures. 3. Able to complete all Patient Reported Outcome Measure (PROM) questionnaires. 4. Fully understands study requirements and able to return for all required follow-up visits and assessments. 5. Able to comply with all post-operative physician prescribed rehabilitation instructions. 6. Index shoulder rotator cuff tendon tear surgical access may be performed using mini-open, single-portal arthroscopic or multi-portal arthroscopic intervention 7. Meets all intended use and indications for use defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include: Index shoulder rotator cuff tendon tear needs management and protection from injury Index shoulder has no substantial loss of tendon tissue Index shoulder rotator cuff tendon tear footprint allows approximation of soft tissue and fixation of the Integrity Implant to tendon tissue using an Integrity Tissue Tack Index shoulder rotator cuff tendon tear footprint allows fixation of the Integrity Implant to bone using the Integrity Bone Staple Exclusion Criteria The subject exclusion criteria are as follows: 1. Medical condition that in the PI's opinion would place the subject at risk or interfere with the study 2. 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) 3. Pregnant, breastfeeding, or plans to become pregnant during the study 4. History of poor compliance with medical treatment of any kind 5. Deemed contraindicated for MRI by the PI 6. Previous rotator cuff surgery (any type) on the index shoulder 7. Current instability of the index shoulder 8. Rotator cuff tendon tear is a Massive Cofield Classified Full-Thickness Tear (tear length \>5cm) 9. Chondromalacia of index shoulder ≥ Grade 3 10. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 11. Insulin dependent Type I Diabetes 12. History of heavy smoking (≥ 1 pack per day) within last 6-months 13. History of auto-immune or immunodeficiency disorders 14. Currently taking immunosuppression medication for other diseases (e.g., transplants or other inflammatory diseases) 15. Oral steroid use in the last 2-months or injectable steroid use in the last 3-months 16. History of cognitive or mental health status that interferes with study participation 17. Poor comprehension of English language 18. Meets one or more of the contraindications defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include: 18.1 Rotator cuff tendon tear is deemed irreparable by the PI 18.2 Rotator cuff tendon tear repair requires replacement of damaged tendon 18.3 Rotator cuff tendon tear repair requires fixation of soft tissue to adjoining soft tissue 18.4 Rotator cuff tendon tear repair requires tendon strength reinforcement 18.5 Presence of infection 18.6 Any condition which would limit the ability or willingness to restrict activities or follow directions during the healing period 18.7 Hypersensitivity to any of the Integrity Implant System components 18.8 Inadequate soft tissue support for Integrity Tissue Tack fixation 18.9 Inadequate quality of bone for Integrity Bone Staple fixation
Where this trial is running
Tampa, Florida and 5 other locations
- Foundation for Orthopaedic Research and Education — Tampa, Florida, United States (Recruiting)
- Central Indiana Orthopaedics — Fishers, Indiana, United States (Recruiting)
- Towson Orthopaedic Associates/University of Maryland St. Joseph's Medical Center — Towson, Maryland, United States (Recruiting)
- Virtua Health — Marlton, New Jersey, United States (Recruiting)
- Steadman Hawkins Clinic of the Carolinas — Greenville, South Carolina, United States (Recruiting)
- Campbell Clinic — Germantown, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Kara Mezger
- Email: kmezger@anika.com
- Phone: 7657710026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.