Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-29 @ 2:35 PM
Study NCT ID:
NCT05014932
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2021-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Noise Induced by Ceramic-ceramic Friction Torques of Total Hip Prostheses With Customized Femoral Stem
Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Organization:
Study Overview
Official Title:
Evaluation of Noise Induced by Ceramic-ceramic Friction Torques of Total Hip Prostheses With Customized Femoral Stem
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATHENS
Brief Summary:
Evaluation of noise induced by ceramic-ceramic friction torques of total hip prostheses with customized femoral stem.
Retrospective and prospective multicentric study.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: