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

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 Overview

• Status: Completed
• Conditions: Shoulder Osteoarthritis
• Intervention / Treatment: Device: shoulder arthroplastis; Device: shoulder arthroplastis

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75016
    • Bizet Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: patient with game-ready splint; 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; - 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.; Device: shoulder arthroplastis; - 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.
Placebo Comparator: patient with standard splint; 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; - 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.; Device: shoulder arthroplastis; - 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clinique Bizet
• Investigators: Principal Investigator: philippe VALENTI, DOCTOR, Clinique Bizet

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 2020-A02470-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No