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Mineral Nano Pathology (MINAPUIH)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Arthroplasty

Treatments

Procedure: hip prosthesis removed metal/metal
Procedure: hip prosthesis removed ceramic/ polyethylene, double mobility
Procedure: hip prosthesis removed metal / polyethylene, double mobility
Procedure: Primary implanted hip prosthesis
Procedure: hip prosthesis removed metal / polyethylene, simple mobility
Procedure: hip prosthesis removed ceramic/ polyethylene, simple mobility
Procedure: hip prosthesis removed ceramic/ceramic

Study type

Observational

Funder types

Other

Identifiers

NCT03898531
2018-A03343-52 (Other Identifier)
69HCL18_0623

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

55 participants in 7 patient groups

hip prosthesis metal/polyethylene in simple mobility
Treatment:
Procedure: hip prosthesis removed metal / polyethylene, simple mobility
hip prosthesis metal/polyethylene in double mobility
Treatment:
Procedure: hip prosthesis removed metal / polyethylene, double mobility
hip prosthesis ceramic/polyethylene in simple mobility
Treatment:
Procedure: hip prosthesis removed ceramic/ polyethylene, simple mobility
hip prosthesis ceramic/polyethylene in double mobility
Treatment:
Procedure: hip prosthesis removed ceramic/ polyethylene, double mobility
Primary implanted hip prosthesis
Treatment:
Procedure: Primary implanted hip prosthesis
metal / metal prosthesis removed
Treatment:
Procedure: hip prosthesis removed metal/metal
ceramic / ceramic prosthesis removed
Treatment:
Procedure: hip prosthesis removed ceramic/ceramic

Trial contacts and locations

2

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Central trial contact

Sebastien Lustig, Pr; Cécile Batailler, Dr

Data sourced from clinicaltrials.gov

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