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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05014932
Acronym
ATHENS
Enrollment
531
Registered
2021-08-20
Start date
2022-02-18
Completion date
2023-03-14
Last updated
2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Complications

Brief summary

Evaluation of noise induced by ceramic-ceramic friction torques of total hip prostheses with customized femoral stem. Retrospective and prospective multicentric study.

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.

Interventions

None listed

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Noise nuisance2 yearsPercentage 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.

Secondary

MeasureTime frameDescription
Oxford Score2 yearsThe 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.
Hip disability and Osteoarthritis Outcome Score (HOOS) Score2 yearsThe 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.
Forgotten Joint Score2 yearsThe 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).
Prosthesis life span2 yearsThe life span of the prosthesis is the time between the implantation of the prosthesis and its complete or partial surgical revision.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026