Follow-up on the Integrity Implant System for shoulder rotator cuff tears

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• OrthoArizona
  Gilbert, Arizona, United States Recruiting
• Premier Orthopaedic Trauma Specialists, PMC
  Pomona, California, United States Recruiting
• Foundation for Orthopaedic Research and Education
  Tampa, Florida, United States Recruiting
• Harbin Clinic
  Rome, Georgia, 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

Study contacts

• Study coordinator: Kara Mezger
• Email: kmezger@anika.com
• Phone: 781-457-9000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.