Mineral Nano Pathology

NCT ID: NCT03898531

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-11

Study Completion Date

2024-07-09

Brief Summary

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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.

Detailed Description

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Conditions

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Arthroplasty

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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hip prosthesis metal/polyethylene in simple mobility

hip prosthesis removed metal / polyethylene, simple mobility

Intervention Type PROCEDURE

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 metal/polyethylene in double mobility

hip prosthesis removed metal / polyethylene, double mobility

Intervention Type PROCEDURE

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 ceramic/polyethylene in simple mobility

hip prosthesis removed ceramic/ polyethylene, simple mobility

Intervention Type PROCEDURE

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 ceramic/polyethylene in double mobility

hip prosthesis removed ceramic/ polyethylene, double mobility

Intervention Type PROCEDURE

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 prosthesis

Primary implanted hip prosthesis

Intervention Type PROCEDURE

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.

metal / metal prosthesis removed

hip prosthesis removed metal/metal

Intervention Type PROCEDURE

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

ceramic / ceramic prosthesis removed

hip prosthesis removed ceramic/ceramic

Intervention Type PROCEDURE

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

Interventions

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hip prosthesis removed ceramic/ceramic

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

Intervention Type PROCEDURE

hip prosthesis removed metal / polyethylene, simple mobility

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

Intervention Type PROCEDURE

hip prosthesis removed metal / polyethylene, double mobility

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

Intervention Type PROCEDURE

hip prosthesis removed ceramic/ polyethylene, simple mobility

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

Intervention Type PROCEDURE

hip prosthesis removed ceramic/ polyethylene, double mobility

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.

Intervention Type PROCEDURE

Primary implanted hip prosthesis

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.

Intervention Type PROCEDURE

hip prosthesis removed metal/metal

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MINAPATH Développement

OTHER

Sponsor Role collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cécile Batailler, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hôpital Edouard Herriot

Lyon, , France

Site Status

Hôpital de la Croix Rousse

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2018-A03343-52

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL18_0623

Identifier Type: -

Identifier Source: org_study_id

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