A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

A Prospective, Single Blinded, Multi-center, Randomized, Controlled, Pivotal Study to Assess the Safety and Effectiveness of the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).

This is a non-inferiority, prospective, single blinded, multi-center, randomized, controlled, pivotal study evaluating the safety and effectiveness of the InSpace™ device as a primary surgical treatment for full thickness MRCT in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure.

Main Inclusion Criteria:

• Positive diagnostic imaging by MRI of the index shoulder indicating a full thickness Massive Rotator Cuff Tear (MRCT), measuring ≥ 5 cm in diameter involving ≥ two tendons (confirmed Intra-operatively)
• Functional deltoid muscle and preserved passive range of motion on physical examination
• Documented VAS score of > 30 mm pain
• Failed non-operative treatment of at least 4 months
• Patient in general good health,independent, and can comply with all post-operative evaluations and visits.

Main Exclusion Criteria:

• Known allergy to the device material (copolymer of PLA and -ε-caprolactone)

• Evidence of the following conditions:

  1. significant gleno-humeral or acromiohumeral arthritis
  2. full thickness cartilage loss as seen on MRI
  3. gleno-humeral instability (excessive translation of the humeral head on the glenoid fossa)
  4. pre-existing deltoid defect or deltoid palsy
  5. major joint trauma, infection or necrosis
  6. partial thickness tears of the supraspinatous
  7. fully reparable rotator cuff tear [Tear of less than 5 cm in diameter (or < 4 cm2) with retractable tendon that can be fully repaired]

• The subject requires concomitant subscapularis repair and/or labral repair

• 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. HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA, etc.)

• Documented evidence of a history 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 breastfeeding or plan to become pregnant during the course of the study

• Concurrent participation in any other investigational clinical study one month prior to enrollment or during the entire study period

• The subject has implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing a MRI scan or has claustrophobia that would inhibit ability to undergo a MRI scan .

• 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.