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

Clinique Bizet

Status

Completed

Conditions

Shoulder Osteoarthritis

Treatments

Device: shoulder arthroplastis

Study type

Interventional

Funder types

Other

Identifiers

NCT04702139

2020-A02470-39

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups, including a placebo group

patient with game-ready splint

Active Comparator group

Description:

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.

Treatment:

Device: shoulder arthroplastis

patient with standard splint

Placebo Comparator group

Description:

Placement of a standard splint immediately after surgery for 2 weeks with ice packs to be used for an average of 8 days.

Treatment:

Device: shoulder arthroplastis