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

NCT ID: NCT04702139

Last Updated: 2024-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2024-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Shoulder Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

shoulder arthroplastis

Intervention Type 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 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.

Group Type PLACEBO_COMPARATOR

shoulder arthroplastis

Intervention Type DEVICE

\- 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Bizet

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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philippe VALENTI, DOCTOR

Role: PRINCIPAL_INVESTIGATOR

Clinique Bizet

Locations

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Bizet Clinic

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2020-A02470-39

Identifier Type: -

Identifier Source: org_study_id

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