Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation

Exclusion Criteria29

• Vulnerable subjects (as defined in ISO 14155)
• Subjects who do not have the power of judgement or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate
• Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
• Previous enrolment into the current investigation,
• Enrolment of the PI, his/her family members, employees and other dependent persons,
• Inability to follow the procedures of the investigation, or known or suspected non-compliance, e.g. due to language problems, psychological disorders, dementia, drug or alcohol abuse, etc. of the subject
• Active smoker
• History of claustrophobia that would prevent an MRI of the index shoulder
• Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder
• Pregnant or planning to become pregnant during the study period
• Breast feeding women
• Subject has conditions or circumstances that would interfere with study requirements.
• Contraindications and limitations of the MD as described in the IFUs.
• Partial rotator cuff tears
• History or known allergy or intolerance to polyester
• Complete full-thickness subscapularis tears greater than the superior 1/3 of the tendon, with Lafosse grade 3 or greater
• Massive rotator cuff tears, tear size equal to or greater than 4 cm in the anterior-posterior dimension or irreparable rotator cuff tear
• Limited space or exposure for implant delivery
• Structural or pathological condition of the bone or soft tissue that could impair healing.
• Intraoperative rotator cuff tear characteristics differ from preoperatively expected characteristics and fulfil one of the abovementioned criteria
• Fatty infiltration of the index shoulder rotator cuff muscle > Goutallier Score 2
• Corticosteroid injection in the operative shoulder within 6 weeks of operation
• Subject shows frozen shoulder/adhesive capsulitis at day of surgery
• Cases of moderate to severe osteoarthritis
• Patients with inflammatory disease or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, arthropathy)
• Subjects with diabetes type I or II
• The subject currently has an acute infection in the area surrounding the surgical site
• Evidence of active infection, osteomyelitis, sepsis or distant infection which could spread to the index joint.
• Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.