Status:
COMPLETED
A Randomized Study of Superiority of POSToperative Pharmaceutical Support on Patients' Knowledge of Their IMPlant
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Joint Prosthesis
Breast Implants
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Recently joint and breast prostheses were placed under special post-marketing surveillance in order to prevent new occurrence of serious incidents by agency for medicines and health products safety. F...
Eligibility Criteria
Inclusion
- Patient aged 18 or over
- Patient hospitalized following the scheduled placement of one of the following prostheses: three-compartment knee prostheses or total hip prosthesis or breast implant
- French-speaking or non-French-speaking patient accompanied by a French-speaking support person
- Patient having received complete information and having signed a free and informed consent for the research
- Patient affiliated to a social security scheme (beneficiary or entitled)
Exclusion
- Patient having been operated on for the installation of an orthopedic prosthesis not programmed within the framework of a trauma emergency.
- Patient suffering from post-operative confusional syndrome;
- Non-French speaking patient unaccompanied or accompanied by a non-French speaking support person
- Patient on state medical aid
- Persons referred to in articles L1121-5, 6 and 8 of the public health code (corresponds to protected persons): pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person subject to legal protection measure, hospitalized for psychiatric disorder.
- Patient who has already had postoperative pharmaceutical support for the placement of the same type of prosthesis on the contralateral limb
- Patient suffering from a known cognitive or memory disorder.
- Patient expressly refusing to participate in the telephone interview
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT04302233
Start Date
May 20 2020
End Date
November 1 2021
Last Update
February 6 2025
Active Locations (1)
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1
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, France, 94010