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

Shoulder Osteoarthritis Clinical Trial

— game-ready  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04702139
• Other study ID #: 2020-A02470-39
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: September 2023
• Source: Clinique Bizet
• Contact: bouchra benkessou
• Phone: 0033143967823
• Email: b.benkessou[@]clinique-bltparis.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Shoulder Osteoarthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Bizet Clinic	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Bizet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the level of postoperative pain following the installation of the Game Ready	Visual Analog Score for pain	9 months
Secondary	risk of stiffness	Physicians Global Assessment to measure risk of stiffness	up to 9 months
Secondary	occurrence of hematoma, edema	Physicians Global Assessment to measure the occurrence of hematoma, edema	up to 9 months
Secondary	length of hospitalization	Physicians Global Assessment to measure the length of hospitalisation	up to 24 hours
Secondary	evolution of mobility	Simple shoulder test, subjective shoulder value, and American Shoulder and Elbow Surgeons Shoulder Score	up to 9 months
Secondary	the time limit for returning to a possible professional activity	Physicians Global Assessment to measure quality of life	up to 3 months