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

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™ 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).

Official Title
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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.

Conditions
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Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV

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


Participation Criteria
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Eligibility Criteria
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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

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 debridment, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair. | Device: Best Repair of torn Rotator Cuff<br> <br> |
| Active Comparator: InSpace™ system<br>Subjects will undergo surgical intervention (usually arthroscopy or mini invasive) of debridment, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system. | Device: InSpace™ system<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of respose rate at each treatment arm | The primary efficacy outcome of the study is considered as the subject response/rehabilitation rate at 6 month post implantation as assesed by the change in the Shoulder Score | 6m | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjects requiring re-operation of the repaired tear at the end of the follow-up period. | Comparison of number of subjects requiring re-operation of the repaired tear at the end of the follow-up period at each tratment arm. | 24 m post implantation | 
| change of total questionnaires scores from baseline to each follow-up visit. | Comparison between the change of total questionnaires scores from baseline to each follow-up visit at each treatment arm. | 6W, 3m, 6m , 12m ,24m | 

 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,