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The aim of the study is to compare the level of postoperative pain after fitting the Game Ready splint, at 48 hours versus that observed with fitting a standard splint
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient with game-ready splint | Active Comparator | Installation of the Game-Ready splint immediately after surgery for 12 hours. They will then be put on the standard splint which they will keep for 2 weeks as for the other group but without ice packs. |
|
| patient with standard splint | Placebo Comparator | Placement of a standard splint immediately after surgery for 2 weeks with ice packs to be used for an average of 8 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| shoulder arthroplastis | Device | - Group (Treatment): Placement of the Game-Ready splint immediately after surgery for 12 hours. They will then be put on the standard splint which they will keep for 2 weeks as for the other group but without ice packs. |
| Measure | Description | Time Frame |
|---|---|---|
| the level of postoperative pain following the installation of the Game Ready | Visual Analog Score for pain | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| risk of stiffness | Physicians Global Assessment to measure risk of stiffness | up to 9 months |
| occurrence of hematoma, edema | Physicians Global Assessment to measure the occurrence of hematoma, edema |
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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 |
|---|---|---|---|---|---|---|
| Bizet Clinic | Paris | 75016 | France |
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| shoulder arthroplastis | Device | - Group (Control): Placement of a standard splint immediately after surgery for 2 weeks with ice packs to be used for an average of 8 days. |
|
| up to 9 months |
| length of hospitalization | Physicians Global Assessment to measure the length of hospitalisation | up to 24 hours |
| evolution of mobility | Simple shoulder test, subjective shoulder value, and American Shoulder and Elbow Surgeons Shoulder Score | up to 9 months |
| the time limit for returning to a possible professional activity | Physicians Global Assessment to measure quality of life | up to 3 months |