Outcomes in Rotator Cuff Repair Using Graft Reinforcement

Exclusion Criteria

• •The patient:
• •1. has irreparable large rotator cuff tears that are found intra-operatively. Note: irreparable is defined by the inability to approximate the tendon to the tuberosity without tension;
• •2. has a rotator cuff tear \< 3cm (measured intra-operatively);
• •3. has a rotator cuff tear \> 5cm (measured intra-operatively);
• •4. has a rotator cuff tear where the subscapularis tendon is disrupted/requires repair;
• •5. has grade 3 or 4 fatty infiltration of the rotator cuff;
• •6. has had prior surgical repair to the affected shoulder;
• •7. is American Society of Anesthesiologists (ASA) Class 4 or 5 (See Appendix I);
• •8. is a tobacco user; unless tobacco free 6 months prior to surgery and willing to remain tobacco free for the duration of the study.
• •9. has lower limb injuries requiring walking assist devices such as crutches and walkers;
• •10. has a known collagen disorder, including systemic lupus erythematous (SLE), rheumatoid arthritis (RA), polymyositis, scleroderma, ankylosing spondylitis, dermatomyositis, osteogenesis imperfecta or the inherited disorders of Sjogren, Larsen, Raynaud, Ehlers-Danlos or Marfan syndrome.
• •11. has obstacles that pose an inordinately high surgical risk, in the judgment of the certified surgeon;
• •12. has co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, chronic steroid use, malnourishment, cancer, or co-existent infection;
• •13. has a history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction;
• •14. is enrolled or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial;
• •15. has any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate.
• •16. has an inability to have a closed MRI conducted.
• •17. needs a re-operation for a re-tear of the rotator cuff.