Joint ProsthesisPOSTIMPNCT04302233
A Randomized Study of Superiority of POSToperative Pharmaceutical Support on Patients' Knowledge of Their IMPlant
A study testing New pharmaceutical support (NPS) in people with Joint Prosthesis and Breast Implants, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Few of french patient are able to identify their prosthesis in the event on health security alert. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Prosthesis, Breast Implants, Health Education
- What is being tested?
- New pharmaceutical support (NPS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2020to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, 94010
About this study
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 :
Read more
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.
- Conditions
- Joint Prosthesis, Breast Implants, Health Education
- Being tested
- New pharmaceutical support (NPS)
- Keywords
- joint prosthesis, breast implants, health education
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New pharmaceutical support (NPS)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| New pharmaceutical support (NPS) | Experimental | An NPS is an interview comprising the following elements:
The delivery of the identification sheet of their implants with:
* a quiz to focus the patient's attention
* a description of the characteristics of their prosthesis using a specific photo of their implant
* a presentation of the medical device vigilance.
* an explanation of the value of the identification sheet for their implant, An in-depth presentation of an information booklet on living at home with their prosthesis and on medical and paramedical monitoring.
For patients in orthopedic surgery: a booklet specific to their prosthesis and the surgical approach For plastic surgery patients, the information sheets published by the French Society of Plastic Reconstructive and Aesthetic Surgery (SOF.CPRE).
A time to answer any questions the patient may have Receives: Other: New pharmaceutical support (NPS) |
| Usual pharmaceutical support (UPS) | No intervention | An UPS is an interview comprising the following elements: * The delivery of the same patient-implant sheet as in arm 1, but without additional oral information. * The delivery and oral presentation of the same booklet as practiced in the arm 1 (NPS). * And a time to answer any questions from the patient months |
What is being measured
The primary outcome is the main question the study is designed to answer.
pourcentage of patients able to recall the correct name of the manufacturer brand or model of their prosthesis after traceability checking by a questionnaire at 6 months postoperative.
Measured: 6 month
Secondary outcomes (21)
pourcentage of patients who recall the reception of a patient-implant file during hospitalization by a questionnaire at 6 months postoperative.
Measured: 6 month
pourcentage of patients able to identify three correct information after traceability checking on the implantation, by a questionnaire at 6 months postoperative
The three requested information are on the card or patient-implant sheet for this outcome are following :
Item 1 : Accurate date of implantation : Date as DD/MM/YYYY format Item 2 : Surgeon's name who placed their prosthesis Item 3 : Batch number of one of the DMI composing their prosthesis : For hip prosthesis, question is about femoral head and for knee prosthesis, question is about tibial insert. If there is implantation of 2 breast prostheses, this is data from right prosthesis which are requested.
Measured: 6 month
pourcentage of patients who recall health institution where the prosthesis was implanted by a questionnaire at 6 months postoperative
Measured: 6 month
pourcentage of patients who know there is a regular medical monitoring after implantation by a questionnaire at 6 months postoperative.
Measured: 6 month
pourcentage of patients who recall material (s) composing the prosthesis by a questionnaire at 6 months postoperative.
Ability of patients to recall correct and useful characteristics for the identification of their prosthesis in the event of a descending health alert (so that the patient knows if he is affected by this alert)
Measured: 6 month
pourcentage of patients with breast implants who recall shape (anatomical or round) and surface texturing (smooth or textured) after traceability checking by a questionnaire at 6 months postoperative
Measured: 6 month
pourcentage of patients with hip prosthesis who recall the location of the operative scar (anterior or posterolateral) and fixing method of the prosthesis (with ciment or without) by a questionnaire at 6 months postoperative
Measured: 6 month
pourcentage of patients know they can report an adverse effect associated with the prosthesis by a questionnaire at 6 months postoperative
Measured: 6 month
pourcentage of patients know institutions able to receive an adverse effect associated with the prosthesis (French agency for medicines and health products (ANSM), industrial, surgeon, other) by a questionnaire at 6 months postoperative.
Measured: 6 month
pourcentage of patients know a prosthesis traceability document (Hospital report, patient card and patient sheet) by a questionnaire at 6 months postoperative.
Measured: 6 month
pourcentage of patients having called the care service and average of call by patient by a questionnaire at 6 months postoperative.
This outcome is an association of four items to assessed the quality and quality medical needs after implantation
Measured: 6 month
pourcentage of patients having consulted outside of Mondor hospital and average of consultation by patient by a questionnaire at 6 months postoperative
Measured: 6 month
pourcentage of patients have been admitted to the emergency by a questionnaire at 6 months postoperative.
Measured: 6 month
pourcentage of patients have been admitted to the hospitalization for a complication related to the prosthesis by a questionnaire at 6 months postoperative
Measured: 6 month
pourcentage of patients having worn already at least one prosthesis before the day of intervention by a questionnaire.
Measured: 6 month
pourcentage of patients wearing always a prosthesis among patient wearing already prostheses keep prosthesis before the day of intervention by a questionnaire.
Measured: 6 month
Average of implant / prosthesis by patient before the day of intervention by a questionnaire.
Measured: 6 month
pourcentage of patients having already a hip, a knee, a breast or an active implantable medical device implant before the day of intervention by a questionnaire
Measured: 6 month
pourcentage of patients knowing all or someone or no one manufacturer name or model of each prosthesis in place before the day of intervention by a questionnaire.
Measured: 6 month
pourcentage of patients knowing the implantation year of each prosthesis before the day of intervention by a questionnaire.
Measured: 6 month
pourcentage of patients able to give the health institution name where previous implant(s) were placed by a questionnaire (Mondor hospital or others).
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start20 May 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Joint ProsthesisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective, multicentric, controlled, single-blind, randomized trial in two parallel arms
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302233
- Sponsor's protocol ID
- APHP200083
- Acronym
- POSTIMP
- Status last verified
- Jan 2025
- First submitted
- 26 Feb 2020
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information
Publications
Tortolano L, Oubaya N, Hacoon J, Paul M, Bregaint T, Benichou L, Flouzat Lachaniette CH, Bosc R, Misandeau Q, Archer V. Impact of a pharmacist-led implant education service on patient knowledge and healthcare-seeking behaviour: the POSTIMP randomised controlled trial. Explor Res Clin Soc Pharm. 2026 Sep 4;24:100840. doi: 10.1016/j.rcsop.2026.100840. eCollection 2026 Dec.
PubMed 42741168
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04302233
- Acronym / sponsor ID
- POSTIMP / APHP200083
- Conditions
- Joint Prosthesis, Breast Implants, Health Education
- Keywords
- joint prosthesis, breast implants, health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a prospective, multicentric, controlled, single-blind, randomized trial in two parallel arms
| Arm | Type | Receives |
|---|---|---|
| New pharmaceutical support (NPS) | Experimental | Other: New pharmaceutical support (NPS)An NPS is an interview comprising the following elements: The delivery of the identification sheet of their implants with: * a quiz to focus the patient's attention * a description of the characteristics of their prosthesis using a specific photo of their implant * a presentation of the medical device vigilance. * an explanation of the value of the identification sheet for their implant, An in-depth presentation of an information booklet on living at home with their prosthesis and on medical and paramedical monitoring. For patients in orthopedic surgery: a booklet specific to their prosthesis and the surgical approach For plastic surgery patients, the information sheets published by the French Society of Plastic Reconstructive and Aesthetic Surgery (SOF.CPRE). A time to answer any questions the patient may have |
| Usual pharmaceutical support (UPS) | No intervention | –An UPS is an interview comprising the following elements: * The delivery of the same patient-implant sheet as in arm 1, but without additional oral information. * The delivery and oral presentation of the same booklet as practiced in the arm 1 (NPS). * And a time to answer any questions from the patient months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New pharmaceutical support (NPS)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. | Other | New pharmaceutical support (NPS) |
Primary outcome
pourcentage of patients able to recall the correct name of the manufacturer brand or model of their prosthesis after traceability checking by a questionnaire at 6 months postoperative.
Time frame: 6 month
21 secondary outcomes
pourcentage of patients who recall the reception of a patient-implant file during hospitalization by a questionnaire at 6 months postoperative.
Time frame: 6 month
pourcentage of patients able to identify three correct information after traceability checking on the implantation, by a questionnaire at 6 months postoperative
Time frame: 6 month
pourcentage of patients who recall health institution where the prosthesis was implanted by a questionnaire at 6 months postoperative
Time frame: 6 month
pourcentage of patients who know there is a regular medical monitoring after implantation by a questionnaire at 6 months postoperative.
Time frame: 6 month
pourcentage of patients who recall material (s) composing the prosthesis by a questionnaire at 6 months postoperative.
Time frame: 6 month
pourcentage of patients with breast implants who recall shape (anatomical or round) and surface texturing (smooth or textured) after traceability checking by a questionnaire at 6 months postoperative
Time frame: 6 month
pourcentage of patients with hip prosthesis who recall the location of the operative scar (anterior or posterolateral) and fixing method of the prosthesis (with ciment or without) by a questionnaire at 6 months postoperative
Time frame: 6 month
pourcentage of patients know they can report an adverse effect associated with the prosthesis by a questionnaire at 6 months postoperative
Time frame: 6 month
pourcentage of patients know institutions able to receive an adverse effect associated with the prosthesis (French agency for medicines and health products (ANSM), industrial, surgeon, other) by a questionnaire at 6 months postoperative.
Time frame: 6 month
pourcentage of patients know a prosthesis traceability document (Hospital report, patient card and patient sheet) by a questionnaire at 6 months postoperative.
Time frame: 6 month
pourcentage of patients having called the care service and average of call by patient by a questionnaire at 6 months postoperative.
Time frame: 6 month
pourcentage of patients having consulted outside of Mondor hospital and average of consultation by patient by a questionnaire at 6 months postoperative
Time frame: 6 month
pourcentage of patients have been admitted to the emergency by a questionnaire at 6 months postoperative.
Time frame: 6 month
pourcentage of patients have been admitted to the hospitalization for a complication related to the prosthesis by a questionnaire at 6 months postoperative
Time frame: 6 month
pourcentage of patients having worn already at least one prosthesis before the day of intervention by a questionnaire.
Time frame: 6 month
pourcentage of patients wearing always a prosthesis among patient wearing already prostheses keep prosthesis before the day of intervention by a questionnaire.
Time frame: 6 month
Average of implant / prosthesis by patient before the day of intervention by a questionnaire.
Time frame: 6 month
pourcentage of patients having already a hip, a knee, a breast or an active implantable medical device implant before the day of intervention by a questionnaire
Time frame: 6 month
pourcentage of patients knowing all or someone or no one manufacturer name or model of each prosthesis in place before the day of intervention by a questionnaire.
Time frame: 6 month
pourcentage of patients knowing the implantation year of each prosthesis before the day of intervention by a questionnaire.
Time frame: 6 month
pourcentage of patients able to give the health institution name where previous implant(s) were placed by a questionnaire (Mondor hospital or others).
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Derived from this study: PubMed 42741168Tortolano L, Oubaya N, Hacoon J, Paul M, Bregaint T, Benichou L, Flouzat Lachaniette CH, Bosc R, Misandeau Q, Archer V. Impact of a pharmacist-led implant education service on patient knowledge and healthcare-seeking behaviour: the POSTIMP randomised controlled trial. Explor Res Clin Soc Pharm. 2026 Sep 4;24:100840. doi: 10.1016/j.rcsop.2026.100840. eCollection 2026 Dec.
- Individual participant dataSharing planned: Yes. data are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New pharmaceutical support (NPS) in people with Joint Prosthesis and Breast Implants, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pourcentage of patients able to recall the correct name of the manufacturer brand or model of their prosthesis after traceability checking by a questionnaire at 6 months postoperative. (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04302233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.