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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04702139

Acronym

game-ready

Enrollment

Registered

2021-01-08

Start date

2021-04-12

Completion date

2024-06-30

Last updated

2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Osteoarthritis

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

Interventions

DEVICEshoulder arthroplastis

\- 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
the level of postoperative pain following the installation of the Game Ready	9 months	Visual Analog Score for pain

Secondary

Measure	Time frame	Description
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
evolution of mobility	up to 9 months	Simple shoulder test, subjective shoulder value, and American Shoulder and Elbow Surgeons Shoulder Score
the time limit for returning to a possible professional activity	up to 3 months	Physicians Global Assessment to measure quality of life

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026