Use of the Game-Ready Splint for Better Recovery in Primary Total Shoulder Arthroplasty

Study Overview
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Brief Summary
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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

Official Title
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Use of the Game-Ready Splint for Better Recovery in Primary Total Shoulder Arthroplasty

Conditions
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Shoulder Osteoarthritis

Intervention / Treatment
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* Device: shoulder arthroplastis
* Device: shoulder arthroplastis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First-line reverse prosthesis Without prosthetic history Patient who has given his consent to participate in the observational study after being informed by the surgeon Patient living in France and able to answer the questionnaire alone. Subject affiliated to a social security scheme or beneficiary of such a scheme Lack of participation in another clinical study Exclusion Criteria: Minor patient Major subject protected by law, under curatorship or tutorship Anterior prosthesis Infection Parkinson's, degenerative neurological disease Pregnant or breastfeeding woman

Ages Eligible for Study
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Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patient with game-ready splint<br>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. | Device: shoulder arthroplastis<br>* - 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.<br>|
| Placebo Comparator: patient with standard splint<br>Placement of a standard splint immediately after surgery for 2 weeks with ice packs to be used for an average of 8 days. | Device: shoulder arthroplastis<br>* - 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the level of postoperative pain following the installation of the Game Ready | Visual Analog Score for pain | 9 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |