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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04702139
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Clinique Bizet

Study Description
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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

Condition or disease Intervention/treatment Phase
Shoulder Osteoarthritis Device: shoulder arthroplastis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of the "Game-Ready" Splint for Better Recovery in Primary Total Shoulder Arthroplasty
Actual Study Start Date : April 12, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : December 1, 2023

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Arms and Interventions
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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.
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 (Control): Placement of a standard splint immediately after surgery for 2 weeks with ice packs to be used for an average of 8 days.


Outcome Measures
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Primary Outcome Measures :
  1. the level of postoperative pain following the installation of the Game Ready [ Time Frame: 9 months ]
    Visual Analog Score for pain


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04702139


Contacts
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Contact: bouchra benkessou 0033143967823 b.benkessou@clinique-bltparis.fr
Contact: imen NID TAHAR 0033143967823 imen.arc@institutparisienepaule.com

Locations
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France
Bizet Clinic Recruiting
Paris, France, 75016
Contact: benkessou BOUCHRA    0764486016    b.benkessou@cliniques-bltparis.fr   
Principal Investigator: valenti philippe, doctor         
Sponsors and Collaborators
Clinique Bizet
Investigators
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Principal Investigator: philippe VALENTI, DOCTOR Clinique Bizet
More Information
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Responsible Party: Clinique Bizet
ClinicalTrials.gov Identifier: NCT04702139    
Other Study ID Numbers: 2020-A02470-39
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases