Mineral Nano Pathology (MINAPUIH)

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.

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty
• Intervention / Treatment: Procedure: hip prosthesis removed metal / polyethylene, simple mobility; Procedure: hip prosthesis removed metal / polyethylene, double mobility; Procedure: hip prosthesis removed ceramic/ polyethylene, simple mobility; Procedure: hip prosthesis removed ceramic/ polyethylene, double mobility; Procedure: Primary implanted hip prosthesis; Procedure: hip prosthesis removed metal/metal; Procedure: hip prosthesis removed ceramic/ceramic

• Study Type: Observational
• Enrollment (Anticipated): 135

Contacts and Locations

• Study Contact: Name: Cecile BATAILLER, DR; Phone Number: +33 04 72 07 19 88; Email: cecile.batailler@chu-lyon.fr
• Study Contact Backup: Name: Sebastien Lustig, Pr; Phone Number: +33 04 72 07 19 88; Email: sebastien.lustig@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Hopital de la Croix Rousse
    • Contact: Cecile BATAILLER, DR; Phone Number: +33 04 72 07 19 88; Email: cecile.batailler@chu-lyon.fr
    • Principal Investigator: Cécile BATAILLER, Dr
  • Lyon, France, 69003
    • Recruiting
    • Hôpital Edouard Herriot
    • Contact: Etienne MASSARDIER, Dr; Phone Number: +33 04 72 11 04 44; Email: etienne.massardier@chu-lyon.fr
    • Sub-Investigator: Etienne MASSARDIER, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
hip prosthesis metal/polyethylene in simple mobility	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
hip prosthesis metal/polyethylene in double mobility	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
hip prosthesis ceramic/polyethylene in simple mobility	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
hip prosthesis ceramic/polyethylene in double mobility	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.
Primary implanted hip prosthesis	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.
metal / metal prosthesis removed	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
ceramic / ceramic prosthesis removed	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Collaborators: MINAPATH Développement
• Investigators: Principal Investigator: Cécile Batailler, Dr, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2019
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: hip arthroplasty; wear particles; hip prosthesis resection; first implantation
• Other Study ID Numbers: 69HCL18_0623; 2018-A03343-52 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No