NCT05014932

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
531

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

February 18, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2023

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

1.1 years

First QC Date

August 16, 2021

Last Update Submit

June 28, 2024

Conditions

Arthroplasty Complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Oxford Score

    2 years

  • Hip disability and Osteoarthritis Outcome Score (HOOS) Score

    2 years

  • Forgotten Joint Score

    2 years

  • Prosthesis life span

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Maussins-Nollet

Paris, 75019, France

Location

Study Officials

  • Alexis NOGIER, MD PD

    Clinique Maussins-Nollet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 20, 2021

Study Start

February 18, 2022

Primary Completion

March 14, 2023

Study Completion

March 14, 2023

Last Updated

July 1, 2024

Record last verified: 2024-06

Locations

FR(1)