Mineral Nano Pathology

Completed

• Conditions: Arthroplasty
• Interventions: Procedure: hip prosthesis removed metal / polyethylene, double mobility; Procedure: Primary implanted hip prosthesis; Procedure: hip prosthesis removed metal/metal; Procedure: hip prosthesis removed metal / polyethylene, simple mobility; Procedure: hip prosthesis removed ceramic/ polyethylene, simple mobility; Procedure: hip prosthesis removed ceramic/ceramic; Procedure: hip prosthesis removed ceramic/ polyethylene, double mobility

• Registration Number: NCT03898531
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-03-29
• Study First Posted: 2019-04-02
• Study Start: 2019-08-11
• Primary Completion: 2024-07-09
• Study Completion: 2024-07-09
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-26
• Last Update Posted: 2024-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hip prosthesis metal/polyethylene in double mobility	hip prosthesis removed metal / polyethylene, double mobility	-
Primary implanted hip prosthesis	Primary implanted hip prosthesis	-
metal / metal prosthesis removed	hip prosthesis removed metal/metal	-
hip prosthesis metal/polyethylene in simple mobility	hip prosthesis removed metal / polyethylene, simple mobility	-
hip prosthesis ceramic/polyethylene in simple mobility	hip prosthesis removed ceramic/ polyethylene, simple mobility	-
ceramic / ceramic prosthesis removed	hip prosthesis removed ceramic/ceramic	-
hip prosthesis ceramic/polyethylene in double mobility	hip prosthesis removed ceramic/ polyethylene, double mobility	-

Primary Outcome Measures

Name	Time	Method
types of particles that cause the most tissue inflammation	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.

Trial Locations

Locations (2)

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France