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

Not Applicable

Completed

• Conditions: Shoulder Osteoarthritis
• Interventions: Device: shoulder arthroplastis

• Registration Number: NCT04702139
• Lead Sponsor: Clinique Bizet

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Study Start: 2021-04-12
• Status Verified: 2023-09
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. First-line reverse prosthesis
2. Without prosthetic history
3. Patient who has given his consent to participate in the observational study after being informed by the surgeon
4. Patient living in France and able to answer the questionnaire alone.
5. Subject affiliated to a social security scheme or beneficiary of such a scheme
6. Lack of participation in another clinical study

Exclusion Criteria

1. Minor patient
2. Major subject protected by law, under curatorship or tutorship
3. Anterior prosthesis
4. Infection
5. Parkinson's, degenerative neurological disease
6. Pregnant or breastfeeding woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patient with standard splint	shoulder arthroplastis	Placement of a standard splint immediately after surgery for 2 weeks with ice packs to be used for an average of 8 days.
patient with game-ready splint	shoulder arthroplastis	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.

Primary Outcome Measures

Name	Time	Method
the level of postoperative pain following the installation of the Game Ready	9 months	Visual Analog Score for pain

Secondary Outcome Measures

Name	Time	Method
risk of stiffness	up to 9 months	Physicians Global Assessment to measure risk of stiffness
occurrence of hematoma, edema	up to 9 months	Physicians Global Assessment to measure the occurrence of hematoma, edema
length of hospitalization	up to 24 hours	Physicians Global Assessment to measure the length of hospitalisation
the time limit for returning to a possible professional activity	up to 3 months	Physicians Global Assessment to measure quality of life
evolution of mobility	up to 9 months	Simple shoulder test, subjective shoulder value, and American Shoulder and Elbow Surgeons Shoulder Score

Trial Locations

Locations (1)

Bizet Clinic; 🇫🇷 Paris, France