ArthroplastyMINAPUIHNCT03898531
Mineral Nano Pathology
An observational study of Arthroplasty, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Hip arthroplasty is a treatment widely used in most inflammatory, traumatic and degenerative conditions of this joint. The longevity of implants may be disappointing in some cases, despite the promising results obtained during in vitro simulations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty
- What is being tested?
- hip prosthesis removed metal / polyethylene, simple mobility, hip prosthesis removed metal / polyethylene, double mobility and hip prosthesis removed ceramic/ polyethylene, simple mobility
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Aug 2019to 9 Jul 2024
- Phase
- Observational
- 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
Study population: Patients will be having a surgery for the resumption of a hip prosthesis or for a first implantation
Who may be able to join
- Adult patient,
- Patient including French,
- Patient witness: to be hospitalized in the orthopedic department of the Croix-Rousse hospital for a first hip prosthesis
- Patient test: to be hospitalized in the orthopedic department of the Croix-Rousse hospital for the removal of a hip prosthesis
Who cannot join
- Patient protected by law (guardianship, curatorship, safeguard of justice).
- Pregnant or lactating woman
- Patient with suspicion of infection on prosthesis
- Patient opposing his participation in the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Edouard Herriot
Lyon, 69003
Hôpital de la Croix Rousse
Lyon, 69004
About this study
Official title: Mineral-Nano-Pathology : Wear of Hip Implants
Hip arthroplasty is a treatment widely used in most inflammatory, traumatic and degenerative conditions of this joint. The longevity of implants may be disappointing in some cases, despite the promising results obtained during in vitro simulations. Early loco-regional or systemic dissemination, known since the 1990s, of wear particles from these prosthesis may reduce their life span.
The analysis of the particles in the synovial fluid and in the articular tissues by electron microscopy after digestion or directly by optical microscopy, will improve the knowledge on the mechanisms of wear.
This category 3 study is based on the case-control model and will be conducted in a national reference center (hospital la Croix-Rousse- Lyon). It will include a population of adult patients.
- Conditions
- Arthroplasty
- Being tested
- hip prosthesis removed metal / polyethylene, simple mobility, hip prosthesis removed metal / polyethylene, double mobility, hip prosthesis removed ceramic/ polyethylene, simple mobility, hip prosthesis removed ceramic/ polyethylene, double mobility, Primary implanted hip prosthesis
- Keywords
- hip arthroplasty, hip prosthesis resection, first implantation, wear particles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip prosthesis removed metal / polyethylene, simple mobilityProcedure or surgery
Patients are hospitalized in order to change their hip prosthesis at the hospital "la Croix-Rousse" in Lyon.
Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust.
The prosthesis removed is composed by metal/polyethylene. It's a simple mobility The aim is to define the types of particles that cause the most tissue inflammation
hip prosthesis removed metal / polyethylene, double mobilityProcedure or surgery
Patients are hospitalized in order to change their hip prosthesis at the hospital "la Croix-Rousse" in Lyon.
Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust.
The prosthesis removed is composed by metal/polyethylene. It's a double mobility.
The aim is to define the types of particles that cause the most tissue inflammation
hip prosthesis removed ceramic/ polyethylene, simple mobilityProcedure or surgery
Patients are hospitalized in order to change for their hip prosthesis at the hospital "la Croix-Rousse" in Lyon.
Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust.
The prosthesis removed is composed by ceramic/polyethylene. It's a simple mobility.
The aim is to define the types of particles that cause the most tissue inflammation
hip prosthesis removed ceramic/ polyethylene, double mobilityProcedure or surgery
Patients are hospitalized in order to change their hip prosthesis at the hospital "la Croix-Rousse" in Lyon.
Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust.
The prosthesis removed is composed by ceramic/polyethylene. It's a double mobility.
The aim is to define the types of particles that cause the most tissue inflammation.
Primary implanted hip prosthesisProcedure or surgery
Patients are hospitalized in order to have a first hip prosthesis at the hospital "la Croix-Rousse" in Lyon.
Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust.
The patients will be received a first prosthesis.
hip prosthesis removed metal/metalProcedure or surgery
Patients are hospitalized in order to change their hip prosthesis at the hospital "la Croix-Rousse" in Lyon.
Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust.
The prosthesis removed is composed by metal/metal. The aim is to define the types of particles that cause the most tissue inflammation
hip prosthesis removed ceramic/ceramicProcedure or surgery
Patients are hospitalized in order to change their hip prosthesis at the hospital "la Croix-Rousse" in Lyon.
Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust.
The prosthesis removed is composed by ceramic/ceramic. The aim is to define the types of particles that cause the most tissue inflammation
| Study group | Role | What they receive |
|---|---|---|
| hip prosthesis metal/polyethylene in simple mobility | Not described Receives: Procedure: hip prosthesis removed metal / polyethylene, simple mobility | |
| hip prosthesis metal/polyethylene in double mobility | Not described Receives: Procedure: hip prosthesis removed metal / polyethylene, double mobility | |
| hip prosthesis ceramic/polyethylene in simple mobility | Not described Receives: Procedure: hip prosthesis removed ceramic/ polyethylene, simple mobility | |
| hip prosthesis ceramic/polyethylene in double mobility | Not described Receives: Procedure: hip prosthesis removed ceramic/ polyethylene, double mobility | |
| Primary implanted hip prosthesis | Not described Receives: Procedure: Primary implanted hip prosthesis | |
| metal / metal prosthesis removed | Not described Receives: Procedure: hip prosthesis removed metal/metal | |
| ceramic / ceramic prosthesis removed | Not described Receives: Procedure: hip prosthesis removed ceramic/ceramic |
What is being measured
The primary outcome is the main question the study is designed to answer.
types of particles that cause the most tissue inflammation
Types of wear particles most found in patients whose tissues are classified as inflammatory. The particles can be classified by size, shape, material and type of original prosthesis.
Measured: day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start11 Aug 2019
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- MINAPATH Développement
- Responsible party
- Sponsor
- Investigators
- Cécile Batailler, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898531
- Sponsor's protocol ID
- 69HCL18_0623
- Other IDs
- 2018-A03343-52
- Acronym
- MINAPUIH
- Status last verified
- Dec 2025
- First submitted
- 29 Mar 2019
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mineral-Nano-Pathology : Wear of Hip Implants
- ClinicalTrials.gov ID
- NCT03898531
- Acronym / sponsor ID
- MINAPUIH / 69HCL18_0623
- Conditions
- Arthroplasty
- Keywords
- hip arthroplasty, hip prosthesis resection, first implantation, wear particles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- MINAPATH Développement
- Study start
- 11 Aug 2019 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 2 Apr 2019 (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.
Hip arthroplasty is a treatment widely used in most inflammatory, traumatic and degenerative conditions of this joint. The longevity of implants may be disappointing in some cases, despite the promising results obtained during in vitro simulations. Early loco-regional or systemic dissemination, known since the 1990s, of wear particles from these prosthesis may reduce their life span.
The analysis of the particles in the synovial fluid and in the articular tissues by electron microscopy after digestion or directly by optical microscopy, will improve the knowledge on the mechanisms of wear.
This category 3 study is based on the case-control model and will be conducted in a national reference center (hospital la Croix-Rousse- Lyon). It will include a population of adult patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| hip prosthesis metal/polyethylene in simple mobility | – | Procedure: hip prosthesis removed metal / polyethylene, simple mobility |
| hip prosthesis metal/polyethylene in double mobility | – | Procedure: hip prosthesis removed metal / polyethylene, double mobility |
| hip prosthesis ceramic/polyethylene in simple mobility | – | Procedure: hip prosthesis removed ceramic/ polyethylene, simple mobility |
| hip prosthesis ceramic/polyethylene in double mobility | – | Procedure: hip prosthesis removed ceramic/ polyethylene, double mobility |
| Primary implanted hip prosthesis | – | Procedure: Primary implanted hip prosthesis |
| metal / metal prosthesis removed | – | Procedure: hip prosthesis removed metal/metal |
| ceramic / ceramic prosthesis removed | – | Procedure: hip prosthesis removed ceramic/ceramic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be having a surgery for the resumption of a hip prosthesis or for a first implantation
Key inclusion criteria (4 listed)
- Adult patient,
- Patient including French,
- Patient witness: to be hospitalized in the orthopedic department of the Croix-Rousse hospital for a first hip prosthesis
- Patient test: to be hospitalized in the orthopedic department of the Croix-Rousse hospital for the removal of a hip prosthesis
Key exclusion criteria (4 listed)
- Patient protected by law (guardianship, curatorship, safeguard of justice).
- Pregnant or lactating woman
- Patient with suspicion of infection on prosthesis
- Patient opposing his participation in the study
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 |
|---|---|---|
| hip prosthesis removed metal / polyethylene, simple mobilityPatients are hospitalized in order to change their hip prosthesis at the hospital "la Croix-Rousse" in Lyon. Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust. The prosthesis removed is composed by metal/polyethylene. It's a simple mobility The aim is to define the types of particles that cause the most tissue inflammation | Procedure or surgery | hip prosthesis metal/polyethylene in simple mobility |
| hip prosthesis removed metal / polyethylene, double mobilityPatients are hospitalized in order to change their hip prosthesis at the hospital "la Croix-Rousse" in Lyon. Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust. The prosthesis removed is composed by metal/polyethylene. It's a double mobility. The aim is to define the types of particles that cause the most tissue inflammation | Procedure or surgery | hip prosthesis metal/polyethylene in double mobility |
| hip prosthesis removed ceramic/ polyethylene, simple mobilityPatients are hospitalized in order to change for their hip prosthesis at the hospital "la Croix-Rousse" in Lyon. Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust. The prosthesis removed is composed by ceramic/polyethylene. It's a simple mobility. The aim is to define the types of particles that cause the most tissue inflammation | Procedure or surgery | hip prosthesis ceramic/polyethylene in simple mobility |
| hip prosthesis removed ceramic/ polyethylene, double mobilityPatients are hospitalized in order to change their hip prosthesis at the hospital "la Croix-Rousse" in Lyon. Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust. The prosthesis removed is composed by ceramic/polyethylene. It's a double mobility. The aim is to define the types of particles that cause the most tissue inflammation. | Procedure or surgery | hip prosthesis ceramic/polyethylene in double mobility |
| Primary implanted hip prosthesisPatients are hospitalized in order to have a first hip prosthesis at the hospital "la Croix-Rousse" in Lyon. Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust. The patients will be received a first prosthesis. | Procedure or surgery | Primary implanted hip prosthesis |
| hip prosthesis removed metal/metalPatients are hospitalized in order to change their hip prosthesis at the hospital "la Croix-Rousse" in Lyon. Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust. The prosthesis removed is composed by metal/metal. The aim is to define the types of particles that cause the most tissue inflammation | Procedure or surgery | metal / metal prosthesis removed |
| hip prosthesis removed ceramic/ceramicPatients are hospitalized in order to change their hip prosthesis at the hospital "la Croix-Rousse" in Lyon. Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust. The prosthesis removed is composed by ceramic/ceramic. The aim is to define the types of particles that cause the most tissue inflammation | Procedure or surgery | ceramic / ceramic prosthesis removed |
Primary outcome
types of particles that cause the most tissue inflammation
Time frame: day of surgery
Types of wear particles most found in patients whose tissues are classified as inflammatory. The particles can be classified by size, shape, material and type of original prosthesis.
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 5 Dec 2025.
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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.
Cécile Batailler, Dr principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, run by Hospices Civils de Lyon at 2 sites 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 4 inclusion and 4 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 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
types of particles that cause the most tissue inflammation (time frame: day of surgery). 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 5 Dec 2025.