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

NCT ID: NCT05014932

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

531 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-18

Study Completion Date

2023-03-14

Brief Summary

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

Retrospective and prospective multicentric study.

Detailed Description

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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.

Conditions

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Arthroplasty Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexis NOGIER, MD PD

Role: PRINCIPAL_INVESTIGATOR

Clinique Maussins-Nollet

Locations

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Clinique Maussins-Nollet

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2020-A02544-35

Identifier Type: -

Identifier Source: org_study_id

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