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Evaluation of Noise Induced by Ceramic-ceramic Friction Torques of Total Hip Prostheses With Customized Femoral Stem (ATHENS)

G

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Completed

Conditions

Arthroplasty Complications

Study type

Observational

Funder types

Other

Identifiers

NCT05014932
2020-A02544-35

Details and patient eligibility

About

Evaluation of noise induced by ceramic-ceramic friction torques of total hip prostheses with customized femoral stem.

Retrospective and prospective multicentric study.

Full description

On a series of patients operated on for more than two years after a total hip arthroplasty that resulted in the implantation of a ceramic-on-ceramic prosthesis with a customized femoral stem:

Primary objective: To assess the frequency of occurrence of joint noise.

Secondary objectives:

  • To describe the characteristics of the noise nuisance (date of onset, frequency, intensity, impact...)
  • To evaluate the individual and surgical factors associated with the occurrence of noise pollution.

Enrollment

531 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient aged 18 years or older, who has been informed of the research
  • Patient who has had a fourth generation ceramic/ceramic hip replacement implanted for at least two years as a first-line replacement
  • Patient who has had a three-dimensional preoperative examination leading to the design and implantation of a custom femoral stem
  • Patient regularly monitored since surgery and for whom all clinical and radiological data are available at the three-month and two-year follow-up visits

Exclusion criteria

  • Patient operated for revision
  • Patient under legal protection, guardianship or curators
  • Patient who has indicated his opposition to the use of his medical data (by completing and returning the non-opposition form which will be sent to him)

Trial contacts and locations

1

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Central trial contact

Alexis NOGIER, MD

Data sourced from clinicaltrials.gov

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