Prosthetic Joint InfectionPROTHEE-QUALINCT07409402
Study of the Lived Experience of Patients With Prosthetic Joint Infection, Their Families, and Healthcare Professionals. Development of a Therapeutic Education Program for Patient Care (TEP).
An observational study of Prosthetic Joint Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The PROTHEE-QUALI study (Qualitative study of the lived experience of patients with prosthetic joint infection, their accompanying persons and health professionals and construction of a therapeutic education program for management: qualitative study) is categorized as non-interventional qualitative research. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infection
- What is being tested?
- Exploration of the lived experience of patients with prosthetic joint infection (PJI), their families, and healthcare professionals
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2026to 2 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients managed in the CRIOAC unit, who underwent surgery for prosthetic joint infection more than one month and less than one year ago and were treated with antibiotic therapy. Relatives or friends designated by the patient, who accompanied them throughout their care, from diagnosis, during and after hospitalisation, at least until the end of the antibiotic therapy. Healthcare professionals (nurses, physiotherapist, psychologists, pharmacists) working for at least one year in the CRIOAC unit.
Who may be able to join
- Patients :
- Age ≥ 18 years
- Have undergone surgery > 1 month and < 1 year ago for a hip, knee, or shoulder prosthetic implant, and are currently receiving or have received prolonged antibiotic therapy (≥ 6 weeks)
- Patients had to agree to sign a consent form to participate in the study.
- Patient companions :
- Age ≥ 18 years
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- Close relative or friend designated by the patient, who has accompanied them throughout their care journey, from diagnosis, during and after hospitalization, at least until the end of antibiotic treatment
- Not opposed to participating in the study
- Healthcare professionals :
- Practicing for ≥ 1 year in a CRIOAC (Reference Center for Osteoarticular Infections)
- Role: nurse, physiotherapist, psychologist, pharmacist
- Not opposed to participating in the study
Who cannot join
- Patients :
- Do not have proficiency in the French language
- Patients with advanced cognitive disorders
- Patients with severe depression
- Patient companions :
- Do not have proficiency in the French language
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- Patients with advanced cognitive disorders
- Patients with severe depression
- Healthcare professionals :
- -None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre de Références des Infections-Ostéo Articulaires Complexes CRIOAC
Paris, France, 75020
ZOE DAVENNE, +33 1 44 64 16 09, zdavenne@hopital-dcss.org
Valérie ZELLER, Pr, +33 1 44 64 17 80, vzeller@hopital-dcss.org
About this study
Official title: Study of the Lived Experience of Patients With Prosthetic Joint Infection, Their Families, and Healthcare Professionals. Development of a Therapeutic Education Program for Patient Care - PROTHEE-QUALI : QUALITATIVE STUDY
The PROTHEE-QUALI study (Qualitative study of the lived experience of patients with prosthetic joint infection, their accompanying persons and health professionals and construction of a therapeutic education program for management: qualitative study) is categorized as non-interventional qualitative research.
In France, a prosthetic joint infection (PJI) is diagnosed in approximately 3000 patients per year. This complication is severe and results in major consequences for the patient, such as prolonged or repeated hospitalization, pain, anxiety, and a transient or permanent loss of autonomy, sometimes resulting in disability, or even amputation or joint resection. PJI management is complex, necessitating a multidisciplinary approach combining surgical treatment and prolonged antibiotic therapy (lasting from 6 to 12 weeks to several months).
Read more
The PROTHEE-QUALI project was designed to create this essential tool by collecting and crossing the perspectives of the affected patients, their accompanying persons, and the healthcare professionals involved.
The general objective of the project is the structuring of a TPE program destined for patients with PJI, aiming to improve their management and support. This includes assistance with adherence to and better tolerance of antibiotic treatments, pain management, physical rehabilitation, psycho-social care, providing information on the infection and its evolution, and adapting hygiene measures.
The primary objective is the exploration of the lived experience of patients with PJI, their accompanying persons, and the health professionals (nurses, physiotherapists, psychologists, and pharmacists) taking care of them in real-life settings.
The secondary objective is the structuring of a TPE program based on the crossed perspectives of patients, their accompanying persons, and health professionals concerning the issue of PJI.
PROTHEE-QUALI is an 18-month prospective multicenter qualitative study. It uses the IPSE qualitative research method ("Inductive process to analyze the structure of lived experience"). The design involves two main phases: Phase 1 focuses on exploring the experience through individual interviews (patients and accompanying persons) and focus groups (health professionals) to extract a structure of experience; Phase 2 involves the validation and elaboration of the TPE program proposal through feedback from new focus groups. The sampling technique used is non-probabilistic and intentional, known as "purposive sampling" with maximum variation, seeking exemplary situations and rich, diversified accounts rather than statistical representativeness.
Involved Structures The research is promoted by the Assistance Publique - Hôpitaux de Paris (AP-HP), with the Délégation à la Recherche Clinique et à l'Innovation (DRCI) ensuring the promoter's missions by delegation. The study is funded by a grant from GIRCI APRESO Convergence 2024.
The research is multicentric, involving three investigating centers which are Complex Osteoarticular Infection Reference Centers (CRIOACs) in the Île de France region:
- The CRIOAC of the Groupe Hospitalier Diaconesses Croix Saint-Simon.
- The CRIOAC Lariboisière Saint Louis.
- The CRIOAC Cochin. The qualitative and methodological team includes members of the INSERM U1153, Statistic and epidemiologic research center Sorbonne Paris Cité. The monitoring of the research is overseen by a Clinical Research Unit (URC).
Read the detailed description
PROTHEE-QUALI is a multicenter, non-interventional qualitative study (RIPH3) designed to explore the lived experience of prosthetic joint infection (PJI) and to use these experiential data to structure a Therapeutic Patient Education (TPE) program tailored to patient needs.
The study is grounded in the IPSE qualitative research method (Inductive Process to Analyze the Structure of Lived Experience), a rigorous phenomenological approach specifically developed for health research. IPSE aims to describe the invariant structure of a lived experience through an inductive, iterative analytic process combining individual and collective phases of analysis.
Data collection is conducted in two successive phases. Phase 1 focuses on accessing the structure of lived experience through individual semi-structured interviews with patients and accompanying persons, and focus groups with healthcare professionals. Phase 2 consists of validation and refinement of the proposed TPE program through new focus groups, using participant feedback on the Phase 1 results and preliminary educational framework.
Analysis follows the IPSE analytic sequence: independent descriptive analysis by several researchers, collective structuring of experiential categories into axes of experience, and triangulation with existing scientific and clinical knowledge to support the elaboration of the TPE program.
The study prioritizes depth of experience and maximum variation over statistical representativeness, in accordance with qualitative research standards.
- Conditions
- Prosthetic Joint Infection
- Being tested
- Exploration of the lived experience of patients with prosthetic joint infection (PJI), their families, and healthcare professionals
- Keywords
- Prosthetic joint infection, Lived experience, Qualitative research, Therapeutic patient education, IPSE method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exploration of the lived experience of patients with prosthetic joint infection (PJI), their families, and healthcare professionalsOther
Organization of individual interviews and group meetings to collect information about the lived experiences of patients, their families, and the healthcare professionals who support them. This data collection will be based on questionnaires and recorded interviews, which will be transcribed verbatim and then analyzed by IPSEA researchers.
| Study group | Role | What they receive |
|---|---|---|
| Interview with participant | Semi-structured, open-ended individual or group interview with a researcher, with an average duration of 1 hour Receives: Other: Exploration of the lived experience of patients with prosthetic joint infection (PJI), their families, and healthcare professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structure of the lived experience of prosthetic joint infection
Qualitative description of the lived experience of prosthetic joint infection among patients, accompanying persons, and healthcare professionals, based on semi-structured individual interviews and focus groups, and analyzed using the IPSE qualitative method (Inductive Process to Analyze the Structure of Lived Experience) Unit of Measure : Emergent experiential categories and axes of experience derived from qualitative analysis
Measured: From inclusion to completion of Phase 1 data analysis (approximately 9 months)
Secondary outcomes (1)
Structuring of a Therapeutic Patient Education (TPE) program for prosthetic joint infection
Development and validation of a Therapeutic Patient Education program for prosthetic joint infection, based on qualitative data collected during Phase 1 and refined through feedback focus groups conducted in Phase 2.
Measurement Tool : Focus groups using semi-structured discussion guides and qualitative thematic feedback analysis (IPSE method) Unit of Measure : Consensus-based experiential dimensions and educational components identified through qualitative analysis
Measured: From Phase 2 focus groups to completion of final qualitative analysis (approximately 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start2 Mar 2026 (estimated)
- Primary completion2 May 2027 (estimated)
- Study completion2 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Joint InfectionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ZOE DAVENNE, Principal investigator, GH Diaconesses Croix Saint Simon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409402
- Sponsor's protocol ID
- APHP251097
- Other IDs
- 2025-A01667-42
- Acronym
- PROTHEE-QUALI
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Lived Experience of Patients With Prosthetic Joint Infection, Their Families, and Healthcare Professionals. Development of a Therapeutic Education Program for Patient Care - PROTHEE-QUALI : QUALITATIVE STUDY
- ClinicalTrials.gov ID
- NCT07409402
- Acronym / sponsor ID
- PROTHEE-QUALI / APHP251097
- Conditions
- Prosthetic Joint Infection
- Keywords
- Prosthetic joint infection, Lived experience, Qualitative research, Therapeutic patient education, IPSE method
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 2 May 2027 (estimated)
- Study completion
- 2 Sep 2027 (estimated)
- First posted
- 13 Feb 2026 (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.
The PROTHEE-QUALI study (Qualitative study of the lived experience of patients with prosthetic joint infection, their accompanying persons and health professionals and construction of a therapeutic education program for management: qualitative study) is categorized as non-interventional qualitative research.
In France, a prosthetic joint infection (PJI) is diagnosed in approximately 3000 patients per year. This complication is severe and results in major consequences for the patient, such as prolonged or repeated hospitalization, pain, anxiety, and a transient or permanent loss of autonomy, sometimes resulting in disability, or even amputation or joint resection. PJI management is complex, necessitating a multidisciplinary approach combining surgical treatment and prolonged antibiotic therapy (lasting from 6 to 12 weeks to several months).
The PROTHEE-QUALI project was designed to create this essential tool by collecting and crossing the perspectives of the affected patients, their accompanying persons, and the healthcare professionals involved.
The general objective of the project is the structuring of a TPE program destined for patients with PJI, aiming to improve their management and support. This includes assistance with adherence to and better tolerance of antibiotic treatments, pain management, physical rehabilitation, psycho-social care, providing information on the infection and its evolution, and adapting hygiene measures.
The primary objective is the exploration of the lived experience of patients with PJI, their accompanying persons, and the health professionals (nurses, physiotherapists, psychologists, and pharmacists) taking care of them in real-life settings.
The secondary objective is the structuring of a TPE program based on the crossed perspectives of patients, their accompanying persons, and health professionals concerning the issue of PJI.
PROTHEE-QUALI is an 18-month prospective multicenter qualitative study. It uses the IPSE qualitative research method ("Inductive process to analyze the structure of lived experience"). The design involves two main phases: Phase 1 focuses on exploring the experience through individual interviews (patients and accompanying persons) and focus groups (health professionals) to extract a structure of experience; Phase 2 involves the validation and elaboration of the TPE program proposal through feedback from new focus groups. The sampling technique used is non-probabilistic and intentional, known as "purposive sampling" with maximum variation, seeking exemplary situations and rich, diversified accounts rather than statistical representativeness.
Involved Structures The research is promoted by the Assistance Publique - Hôpitaux de Paris (AP-HP), with the Délégation à la Recherche Clinique et à l'Innovation (DRCI) ensuring the promoter's missions by delegation. The study is funded by a grant from GIRCI APRESO Convergence 2024.
The research is multicentric, involving three investigating centers which are Complex Osteoarticular Infection Reference Centers (CRIOACs) in the Île de France region:
- The CRIOAC of the Groupe Hospitalier Diaconesses Croix Saint-Simon.
- The CRIOAC Lariboisière Saint Louis.
- The CRIOAC Cochin. The qualitative and methodological team includes members of the INSERM U1153, Statistic and epidemiologic research center Sorbonne Paris Cité. The monitoring of the research is overseen by a Clinical Research Unit (URC).
Detailed description
PROTHEE-QUALI is a multicenter, non-interventional qualitative study (RIPH3) designed to explore the lived experience of prosthetic joint infection (PJI) and to use these experiential data to structure a Therapeutic Patient Education (TPE) program tailored to patient needs.
The study is grounded in the IPSE qualitative research method (Inductive Process to Analyze the Structure of Lived Experience), a rigorous phenomenological approach specifically developed for health research. IPSE aims to describe the invariant structure of a lived experience through an inductive, iterative analytic process combining individual and collective phases of analysis.
Data collection is conducted in two successive phases. Phase 1 focuses on accessing the structure of lived experience through individual semi-structured interviews with patients and accompanying persons, and focus groups with healthcare professionals. Phase 2 consists of validation and refinement of the proposed TPE program through new focus groups, using participant feedback on the Phase 1 results and preliminary educational framework.
Analysis follows the IPSE analytic sequence: independent descriptive analysis by several researchers, collective structuring of experiential categories into axes of experience, and triangulation with existing scientific and clinical knowledge to support the elaboration of the TPE program.
The study prioritizes depth of experience and maximum variation over statistical representativeness, in accordance with qualitative research standards.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interview with participant | – | Other: Exploration of the lived experience of patients with prosthetic joint infection (PJI), their families, and healthcare professionalsSemi-structured, open-ended individual or group interview with a researcher, with an average duration of 1 hour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients managed in the CRIOAC unit, who underwent surgery for prosthetic joint infection more than one month and less than one year ago and were treated with antibiotic therapy. Relatives or friends designated by the patient, who accompanied them throughout their care, from diagnosis, during and after hospitalisation, at least until the end of the antibiotic therapy. Healthcare professionals (nurses, physiotherapist, psychologists, pharmacists) working for at least one year in the CRIOAC unit.
Key inclusion criteria (12 listed)
- Age ≥ 18 years
- Have undergone surgery > 1 month and < 1 year ago for a hip, knee, or shoulder prosthetic implant, and are currently receiving or have received prolonged antibiotic therapy (≥ 6 weeks)
- Patients had to agree to sign a consent form to participate in the study.
- Age ≥ 18 years
- Close relative or friend designated by the patient, who has accompanied them throughout their care journey, from diagnosis, during and after hospitalization, at least until the end of antibiotic treatment
Key exclusion criteria (10 listed)
- Do not have proficiency in the French language
- Patients with advanced cognitive disorders
- Patients with severe depression
- Do not have proficiency in the French language
- Patients with advanced cognitive disorders
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 |
|---|---|---|
| Exploration of the lived experience of patients with prosthetic joint infection (PJI), their families, and healthcare professionalsOrganization of individual interviews and group meetings to collect information about the lived experiences of patients, their families, and the healthcare professionals who support them. This data collection will be based on questionnaires and recorded interviews, which will be transcribed verbatim and then analyzed by IPSEA researchers. | Other | Interview with participant |
Primary outcome
Structure of the lived experience of prosthetic joint infection
Time frame: From inclusion to completion of Phase 1 data analysis (approximately 9 months)
Qualitative description of the lived experience of prosthetic joint infection among patients, accompanying persons, and healthcare professionals, based on semi-structured individual interviews and focus groups, and analyzed using the IPSE qualitative method (Inductive Process to Analyze the Structure of Lived Experience) Unit of Measure : Emergent experiential categories and axes of experience derived from qualitative analysis
1 secondary outcome
Structuring of a Therapeutic Patient Education (TPE) program for prosthetic joint infection
Time frame: From Phase 2 focus groups to completion of final qualitative analysis (approximately 3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Prosthetic Joint Infection
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A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
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Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
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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.
ZOE DAVENNE principal investigator
GH Diaconesses Croix Saint Simon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthetic Joint Infection, 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 12 inclusion and 10 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: opening soon, as of the sponsor's last update on 13 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZOE DAVENNE (+33 1 44 64 16 09, zdavenne@hopital-dcss.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structure of the lived experience of prosthetic joint infection (time frame: From inclusion to completion of Phase 1 data analysis (approximately 9 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2026.