Rotator Cuff Tear
Conditions
Keywords
Massive Rotator Cuff Tear, Sub-acromial spacer, Best repair of rotator cuff
Brief summary
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ in the study population in comparison to surgical RCT repair.
Detailed description
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).
Interventions
DEVICEInSpace™ system over repair
PROCEDUREBest Repair of torn Rotator Cuff
Sponsors
OrthoSpace Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Age 40 or older. * Positive diagnostic MRI of the affected shoulder indicating full thickness large to massive RCT of at least 3cm in diameter (according to Cofield classification2) involving one or more tendons. (MRI can be done up to 6 months prior to randomization.) * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the Shoulder Score | baseline and 6 months |
Countries
Israel
Outcome results
None listed