Accelerated rehabilitation for rotator cuff tears using the InSpace device

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