Health Education, Joint Prosthesis, Breast Implants Clinical Trial
Official title:
A Randomized, Controlled Study of the Superiority Between 2 Types of POSToperative Pharmaceutical Support on Patients' Knowledge of Their IMPlant: Breast or Joint Prostheses
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. Few of french patient are able to identify their prosthesis in the event on
health security alert. An usual postoperative pharmaceutical support (UPS) for patients with
joint prosthesis has been implemented to prepare them for return home. At the request of
surgeons, a new pharmaceutical support (NPS) has been developed to improve the ability of
these patients to recall or find information that identify their prosthesis.
Objectives :
The main objective is to demonstrate that the new pharmaceutical support (NPS) increase the
ability to memorize then find correct information of their prosthesis 6 months
post-implantation
Material and method :
This study, approved by an ethic committee, takes place in the orthopedic and plastic surgery
departments. The 236 adult patients included are hospitalized following the scheduled
placement of either a breast or a hip or knee prosthesis. They are randomized, either in the
NPS group or in the UPS comparator group. In both cases, patients benefit from the same
written information: a patient-implant file and an information booklet specific to their
prosthesis, validated by specialist surgeons, to prepare for their return home. The only
difference between these 2 groups is that patients in the NPS group benefit from additional
visual and oral information on the characteristics of their implant and on medical device
vigilance during their hospitalization. In NPS group, pharmacist use specific photo and quiz.
A telephone follow-up at the 6th month of the patients is carried out by a pharmacist to
assess the patient's knowledge, using a standardized questionnaire.
Expected results :
Based on retrospective data already published, the main hypothesis is that the NPS is
associated with an improvement in patient ability to remember the correct model or
manufacturer of their prosthesis, compared to the UPS, 6 months after the operation.Secondary
hypotheses are that NPS compared to UPS leads to an improvement in patients ability to
preserve and find correct items related to theirs prosthesis at 6 months as well as an
improvement in their knowledge of medical device vigilance and patient satisfaction
declarations and a decrease in anxiety associated with prosthesis.
n/a