Mineral Nano Pathology

NCT03898531 | Completed

• 2 other identifiers: 69HCL18_06232018-A03343-52
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

hip arthroplasty; hip prosthesis resection; first implantation; wear particles

Outcome Measures

Primary Outcomes (1)

• 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.

  day of surgery

Study Arms (7)

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

Interventions

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 ceramic/polyethylene in simple mobility

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 metal/polyethylene in simple mobility

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 metal/polyethylene in double mobility

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.

hip prosthesis ceramic/polyethylene in double mobility

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.

Primary implanted hip 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

metal / metal prosthesis removed

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

ceramic / ceramic prosthesis removed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be having a surgery for the resumption of a hip prosthesis or for a first implantation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• MINAPATH Développement: collaborator

Study Sites (2)

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* The synovial fluid is removed by syringe during the surgery, * the resected synovial membrane is retrieved, * the femoral head or components removed from the prosthesis are retrieved, * routine biological sampling is performed during surgery to assess the patient's infectious condition

MeSH Terms

Interventions

Polyethylene; Metals; Ceramics

Intervention Hierarchy (Ancestors)

Polyethylenes; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Inorganic Chemicals

Study Officials

• Cécile Batailler, Dr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 2, 2019
• Study Start: August 11, 2019
• Primary Completion: July 9, 2024
• Study Completion: July 9, 2024
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

FR (2)