InSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Randomized, Two-arm, Prospective Study to Assess the Efficacy and Safety of InSpace™ Device Implanted Over a Rotator Cuff Repair in Comparison With Rotator Cuff Repair Only

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Device: InSpace™ system over repair
* Procedure: Best Repair of torn Rotator Cuff


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Best Repair of torn Rotator Cuff<br>Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair. | Procedure: Best Repair of torn Rotator Cuff<br> <br> |
| Active Comparator: InSpace™ system<br>Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair, and placement of the InSpace™ system. | Device: InSpace™ system over repair<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the Shoulder Score |  | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massive Rotator Cuff Tear, Sub-acromial spacer, Best repair of rotator cuff