Integrity Implant System Post Market Clinical Follow-Up Study

Exclusion Criteria

• •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