UAMS - Translational Research Institute

Subjects MUST meet ALL the following criteria to be included in the study: - The subject has signed the IRB approved Informed Consent Form (ICF) specific to this study prior to enrollment - Is male or female ≥ sixty-five (65) years of age - Positive diagnostic imaging by MRI within 9 months of enrollment of the index shoulder indicating a full thickness MRCT: - Measuring ≥ 5 cm in diameter - Involving ≥ two tendons - Functional deltoid muscle and preserved passive range of motion on physical examination - Documented VAS score > 30 mm pain - Failed non-operative treatment of at least 3 months from the initial treatment to include one or more of the following: - Oral analgesics - Anti-inflammatory medication (e.g., ibuprofen, naproxen) - Corticosteroid injection(s) - Physical therapy - Activity modification - Rest (sling used) - Must be able to read and understand the approved Informed Consent Form (written and oral) - Must be in general good health (as determined by the Investigator) based on screening assessments and medical history - Must be independent, ambulatory, and can comply with all post-operative evaluations, visits, and electronic database collection Intra-operative Inclusion Criteria Subjects MUST meet the following criteria to be randomized in the study: - Full thickness tear - Tear size ≥ 5 cm in diameter - Tear involving ≥ two tendons

Subjects will be excluded from the study, if they meet ANY of the following individual exclusion criteria: - Known allergy to the device material (copolymer of PLA (poly (lactic acid) and -ε-caprolactone) - Evidence of the following conditions: - Severe gleno-humeral or acromio-humeral arthritis - Full thickness cartilage loss as seen on MRI - History within the past 5 years of anterior or posterior shoulder subluxation or dislocation as determined by history, examination, or radiographic findings - Pre-existing deltoid defect or deltoid palsy - Major joint trauma, infection, or necrosis - Partial thickness tears of the supraspinatus - Fully reparable rotator cuff tear [Tear of less than 5 cm in diameter (or < 4 cm2) with retractable tendon that can be fully repaired] - Known neurovascular compromise - Complete deltoid muscle palsy - Traumatic muscle tears of the pectoralis or deltoid - The subject requires concomitant: - Subscapularis repair - Labral repair of any type - Biceps tenodesis - Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy - The subject's condition is bilateral and rotator cuff repair is scheduled or to be scheduled over the course of this study for the contra lateral shoulder - Major medical condition that could affect quality of life and influence the results of the study (e.g., rheumatoid arthritis) - The subject has documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment - The subject's condition represents a worker's compensation case - The subject is currently involved in a health-related litigation procedure - Females of child-bearing potential who are pregnant or plan to become pregnant. - Concurrent participation in an investigational clinical study one month prior to enrollment or during the entire study period - The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant to follow-up - The subject is receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition - The subject currently has an acute infection in the area surrounding the surgical site. - Baseline WORC score less than 420 Intra-operative Exclusion Criteria: Subjects will not be randomized and will be terminated from the study if they meet ANY of the following individual intra-operative exclusion criteria: - Rotator cuff is/presents with: - Fully reparable with adequate tissue and muscle quality (equivalent to Goutallier stage 1 or 2) - Partial thickness tear of the supraspinatus - Evidence of significant osteoarthritis - The subject requires concomitant: - Subscapularis repair - Labral repair of any type - Biceps tenodesis - Coracoacromial ligament functional deficiency or shoulder instability is identified