Mineral Nano Pathology

Arthroplasty Clinical Trial

— MINAPUIH  

Official title:

Mineral-Nano-Pathology : Wear of Hip Implants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03898531
• Other study ID #: 69HCL18_0623
• Secondary ID: 2018-A03343-52
• Status: Recruiting
• Start date: August 11, 2019
• Est. completion date: December 2024

Study information

• Verified date: April 2022
• Source: Hospices Civils de Lyon
• Contact: Cécile Batailler, Dr
• Phone: 04 72 07 19 88
• Email: cecile.batailler[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty

Intervention

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 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 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 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
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
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
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

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse	Lyon
France	Hôpital Edouard Herriot	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	MINAPATH Développement

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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