Clinical Research Directory

Inclusion Criteria: 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 Exclusion Criteria: 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