InSpace Accelerated Rehabilitation Study

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 thisstudy 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 indexshoulder indicating a full thickness MRCT:

• Measuring ≥ 5 cm in diameter

• Involving ≥ two tendons

• Functional deltoid muscle and preserved passive range of motion on physicalexamination

• Documented VAS score > 30 mm pain

• Failed non-operative treatment of at least 3 months from the initial treatment toinclude 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 andoral)

• Must be in general good health (as determined by the Investigator) based onscreening 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 subluxationor 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 < 4cm2) 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 diagnosticarthroscopy

• The subject's condition is bilateral and rotator cuff repair is scheduled or to bescheduled over the course of this study for the contra lateral shoulder

• Major medical condition that could affect quality of life and influence the resultsof the study (e.g., rheumatoid arthritis)

• The subject has documented evidence of a history (e.g., liver testing) ofdrug/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 toenrollment or during the entire study period

• The subject is physically or mentally compromised (e.g., currently being treated fora psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extentthat the Investigator judges the subject to be unable or unlikely to remaincompliant to follow-up

• The subject is receiving prescription narcotic pain medication for conditionsunrelated to the index shoulder condition

• The subject currently has an acute infection in the area surrounding the surgicalsite.

• 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 toGoutallier 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