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Evaluate the re-rupture rate 12 months following the intervention in a group with and a group without a spacer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient with inspace device | Active Comparator |
| |
| patient without inspace device | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repair of a cuff tear | Device | Group (Treatment): Arthroscopic Implantation of the System InSpace on a repaired rotator cuff tendon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the re-rupture rate | with radiological imaging | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate mobility | the Constant score | up to 12 months |
| Assess shoulder pain | VISUAL ANALOGIC SCALE | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| philippe VALENTI, DOCTOR | Clinique Bizet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Bizet | Paris | 75016 | France |
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| repair of a cuff tear | Device | Group (Control): standard Arthroscopic repair of the cuff rotator |
|
| the quality of life assessed | Simple Shoulder Test, Subjective Shoulder Value and American Shoulder and Elbow Surgeons Shoulder Score | up to 12 months |
| resumption of work | Physicians Global Assessment for resumption of work | up to 12 months |