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

Clinique Bizet40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Shoulder Osteoarthritis

Interventions

shoulder arthroplastisDEVICE

\- 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.

shoulder arthroplastisDEVICE

\- 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Bizet Clinic

Paris, France

Outcomes

Primary Outcomes

the level of postoperative pain following the installation of the Game Ready

Visual Analog Score for pain

Time frame: 9 months

Secondary Outcomes

risk of stiffness

Physicians Global Assessment to measure risk of stiffness

Time frame: up to 9 months

occurrence of hematoma, edema

Physicians Global Assessment to measure the occurrence of hematoma, edema

Time frame: up to 9 months

length of hospitalization

Physicians Global Assessment to measure the length of hospitalisation

Time frame: up to 24 hours

evolution of mobility

Simple shoulder test, subjective shoulder value, and American Shoulder and Elbow Surgeons Shoulder Score

Time frame: up to 9 months

the time limit for returning to a possible professional activity

Physicians Global Assessment to measure quality of life

Time frame: up to 3 months

Data from ClinicalTrials.gov

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