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

Arthroplasty Complications Clinical Trial

— ATHENS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05014932
• Other study ID #: 2020-A02544-35
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: February 2022

Study information

• Verified date: August 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Alexis NOGIER, MD
• Phone: 06 60 14 83 13
• Email: alexis.nogier[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Retrospective and prospective multicentric study.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthroplasty Complications

Locations

Country	Name	City	State
France	Clinique Maussins-Nollet	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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