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

NCT04702139 | Completed

• 1 other identifier: 2020-A02470-39
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Shoulder Osteoarthritis

Outcome Measures

Primary Outcomes (1)

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

  Visual Analog Score for pain

  9 months

Secondary Outcomes (5)

• risk of stiffness

  up to 9 months

• occurrence of hematoma, edema

  up to 9 months

• length of hospitalization

  up to 24 hours

• evolution of mobility

  up to 9 months

• the time limit for returning to a possible professional activity

  up to 3 months

Study Arms (2)

patient with game-ready splint

ACTIVE COMPARATOR

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

patient with standard splint

PLACEBO COMPARATOR

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

Interventions

shoulder arthroplastis DEVICE

\- 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.

patient with game-ready splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Minor patient
• Major subject protected by law, under curatorship or tutorship
• Anterior prosthesis
• Infection
• Parkinson's, degenerative neurological disease
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• Clinique Bizet: lead

Study Sites (1)

Bizet Clinic

Paris, 75016, France

Location

Study Officials

• philippe VALENTI, DOCTOR

  Clinique Bizet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: April 12, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: November 14, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)