Skip to main content
Clinical Trials/NCT03898531
NCT03898531
Completed
Not Applicable

Mineral-Nano-Pathology : Wear of Hip Implants

Hospices Civils de Lyon2 sites in 1 country135 target enrollmentAugust 11, 2019
ConditionsArthroplasty

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthroplasty
Sponsor
Hospices Civils de Lyon
Enrollment
135
Locations
2
Primary Endpoint
types of particles that cause the most tissue inflammation
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 11, 2019
End Date
July 9, 2024
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (2)

Loading locations...

Similar Trials