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Completed

NCT Number: NCT03898531

Mineral Nano Pathology

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.

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Key information

Conditions

Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Edouard Herriot, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hip prosthesis removed metal / polyethylene, simple mobility

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 removed metal / polyethylene, double mobility

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 removed ceramic/ polyethylene, simple mobility

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 removed ceramic/ polyethylene, double mobility

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

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.

hip prosthesis removed metal/metal

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

hip prosthesis removed ceramic/ceramic

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

  • MINAPATH Développement

Registry information

Official study title

Mineral-Nano-Pathology : Wear of Hip Implants

Acronym: MINAPUIH

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 2, 2019
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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