InSpace Accelerated Rehabilitation Study

Study Objectives:

Primary:

• To evaluate clinical outcomes of both a formalized or an at-home rehabilitation program when used in conjunction with the InSpace device as compared to the corresponding InSpace Pivotal study results.

• To demonstrate consistency of each intervention group with the corresponding historical control study results.
• To demonstrate that comparable clinical outcomes can be achieved for each intervention group.

Secondary:

• Change in clinical outcomes compared to baseline.

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