InSpace Accelerated Rehabilitation Study

Exclusion Criteria37

• 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
• 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