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Completed

NCT Number: NCT04702139

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

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

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Key information

Conditions

Shoulder Osteoarthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bizet Clinic

Paris, 75016, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 9 months

    Visual Analog Score for pain

Secondary outcomes

  1. risk of stiffness

    Time frame: up to 9 months

    Physicians Global Assessment to measure risk of stiffness

  2. occurrence of hematoma, edema

    Time frame: up to 9 months

    Physicians Global Assessment to measure the occurrence of hematoma, edema

  3. length of hospitalization

    Time frame: up to 24 hours

    Physicians Global Assessment to measure the length of hospitalisation

  4. evolution of mobility

    Time frame: up to 9 months

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

  5. the time limit for returning to a possible professional activity

    Time frame: up to 3 months

    Physicians Global Assessment to measure quality of life

Sponsors and collaborators

Lead sponsor

Clinique Bizet

Other

Registry information

Acronym: game-ready

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 8, 2021
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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