InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.

A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Efficacy and Safety of InSpace™ Device in Comparison to Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.

This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .

The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living(ADL) and improvement of range of motion (ROM).

Main Inclusion Criteria:

• Age 40 or older.
• Positive diagnostic imaging (CT arthrogram or MRI)* of the affected shoulder indicating full thickness Massive RCT of at least 5cm in diameter (according to Cofield classification) or long - narrow tears of at least 4cm2 (W>2cm and L>2cm) including fatty infiltration grade III or IV (according to classification of Goutallier) involving more than one tendon. - Persistent pain and functional disability of the affected shoulder for at least 3 months.

Main Exclusion Criteria :

• Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
• Evidence of significant osteoarthritis or cartilage damage in the shoulder
• Evidence of gleno-humeral instability
• Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
• Evidence of major joint trauma, infection, or necrosis in the shoulder
• Partial-thickness tears of the rotator cuff