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

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

Retrospective and prospective multicentric study.

Study Overview

• Status: Completed
• Conditions: Arthroplasty Complications

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 531

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Clinique Maussins-Nollet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with at least two years of uncemented fourth generation ceramic/ceramic total hip replacement with customised femoral stem.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noise nuisance	Percentage of occurrence of noise nuisance (assessed in relation to the total number of patients and the total number of prostheses). The frequency of occurrence of noise nuisance will be analysed descriptively. The time elapsed until the occurrence of the noise nuisance will be additionally assessed by a Kaplan-Meier analysis.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Score	The Oxford Hip Score questionnaire (OHS 12) consists of 12 questions. It measures pain (6 items) and hip function (6 items) in relation to activities of daily living such as walking, dressing and sleep disturbance. Each question has 5 possible answers. Each has a value from 0 to 4, with 0 representing the highest level of severity and 4 representing no or almost no symptoms.	2 years
Hip disability and Osteoarthritis Outcome Score (HOOS) Score	The HOOS questionnaire is a self-administered questionnaire specific to hip arthroplasty. It consists of 40 questions with 5 domains: 5 questions on symptoms and stiffness; 10 questions on pain; 17 questions on functional results in daily life; 4 questions on sport and leisure activities; 4 questions on quality of life. It includes 5 sub-scores, one sub-score per domain.	2 years
Forgotten Joint Score	The Forgotten Joint Score (FJS-12) is a self-administered questionnaire consisting of 12 questions assessing the degree of forgetfulness of hip replacements in a given situation of daily life. Each answer is selected from a 5-point Likert scale with response options ranging from never (0) to most of the time (4).	2 years
Prosthesis life span	The life span of the prosthesis is the time between the implantation of the prosthesis and its complete or partial surgical revision.	2 years

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Alexis NOGIER, MD PD, Clinique Maussins-Nollet

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Actual): March 14, 2023
• Study Completion (Actual): March 14, 2023

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2020-A02544-35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No