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Mineral Nano Pathology (MINAPUIH)

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ClinicalTrials.gov Identifier: NCT03898531
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
MINAPATH Développement
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Arthroplasty 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

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Study Type : Observational
Estimated Enrollment : 135 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mineral-Nano-Pathology : Wear of Hip Implants
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

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





Primary Outcome Measures :
  1. 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.


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be having a surgery for the resumption of a hip prosthesis or for a first implantation
Criteria

Inclusion Criteria:

  • Patient 18 to 80 years old,
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898531


Contacts
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Contact: Valentin Massardier 6 04 03 66 41 ext +33 valentin.massardier@insa-lyon.fr
Contact: Cécile Batailler, Dr 4 26 10 38 34 ext +33 cecile.batailler@chu-lyon.fr

Locations
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France
Hôpital de la Croix Rousse Not yet recruiting
Lyon, France, 69004
Contact: Valentin Massardier         
Principal Investigator: Cécile Batailler, Dr         
Sponsors and Collaborators
Hospices Civils de Lyon
MINAPATH Développement
Investigators
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Principal Investigator: Cécile Batailler Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03898531     History of Changes
Other Study ID Numbers: 69HCL18_0623
2018-A03343-52 ( Other Identifier: ANSM )
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
hip arthroplasty
hip prosthesis resection
first implantation
wear particles