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

Primary Purpose

Shoulder Osteoarthritis

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

shoulder arthroplastis

About this trial

This is an interventional other trial for Shoulder Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Bizet ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

patient with game-ready splint

patient with standard splint

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Visual Analog Score for pain

Secondary Outcome Measures

risk of stiffness

Physicians Global Assessment to measure risk of stiffness

occurrence of hematoma, edema

Physicians Global Assessment to measure the occurrence of hematoma, edema

length of hospitalization

Physicians Global Assessment to measure the length of hospitalisation

evolution of mobility

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

the time limit for returning to a possible professional activity

Physicians Global Assessment to measure quality of life

Full Information

NCT ID

NCT04702139

First Posted

January 6, 2021

Last Updated

September 26, 2023

Sponsor

Clinique Bizet

1. Study Identification

Unique Protocol Identification Number

NCT04702139

Brief Title

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

Acronym

game-ready

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 12, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clinique Bizet

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Osteoarthritis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patient with game-ready splint

Arm Type

Active Comparator

Arm Description

Arm Title

patient with standard splint

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

shoulder arthroplastis

Intervention Description

- 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.

Intervention Type

Device

Intervention Name(s)

shoulder arthroplastis

Intervention Description

- 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.

Primary Outcome Measure Information:

Title

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

Description

Visual Analog Score for pain

Time Frame

9 months

Secondary Outcome Measure Information:

Title

risk of stiffness

Description

Physicians Global Assessment to measure risk of stiffness

Time Frame

up to 9 months

Title

occurrence of hematoma, edema

Description

Physicians Global Assessment to measure the occurrence of hematoma, edema

Time Frame

up to 9 months

Title

length of hospitalization

Description

Physicians Global Assessment to measure the length of hospitalisation

Time Frame

up to 24 hours

Title

evolution of mobility

Description

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

Time Frame

up to 9 months

Title

the time limit for returning to a possible professional activity

Description

Physicians Global Assessment to measure quality of life

Time Frame

up to 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

bouchra benkessou

Phone

0033143967823

b.benkessou@clinique-bltparis.fr

First Name & Middle Initial & Last Name or Official Title & Degree

imen NID TAHAR

Phone

0033143967823

imen.arc@institutparisienepaule.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

philippe VALENTI, DOCTOR

Organizational Affiliation

Clinique Bizet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bizet Clinic

City

Paris

ZIP/Postal Code

75016

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

benkessou BOUCHRA

Phone

0764486016

b.benkessou@cliniques-bltparis.fr

First Name & Middle Initial & Last Name & Degree

valenti philippe, doctor

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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