NCT03505580

Brief Summary

The purpose of this study is to evaluate radiological performance of the cementless femoral stem AMIStem H at 1 and 5-year follow-up. All the patients operated at the investigational sites between April 2009 and April 2012 will be reviewed at 1, 5 and 10 year according to standard practice

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

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

Study Start

First participant enrolled

October 1, 2013

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

9.3 years

First QC Date

April 16, 2018

Last Update Submit

September 23, 2025

Conditions

Hip Replacement Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Presence of radiolucencies

    5 years

Secondary Outcomes (4)

  • correlation between the presence of radiolucencies and patient/implant characteristics

    5 years, 10 years

  • evaluation of radiolucent lines progression

    1 years, 10 years

  • evaluation of radiolucent lines progression

    5 years, 10 years

  • Record of adverse events

    1, 5 years and 10 years

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All the patients who undewent total hip arthroplasty with AMIStem-H cementless femoral stem at the investigational sites between April 2009 and April 2012

You may qualify if:

  • patients who underwent total hip arthroplasty at the investigational sites between April 2009 and April 2012
  • patients bearing an AMIStem-H cementless femoral stem

You may not qualify if:

  • patients who refuse to give consent for the treatment of data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique Paris V

Paris, France, 75005, France

Location

Clinique du Cèdre

Bois-Guillaume, 76230, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 23, 2018

Study Start

October 1, 2013

Primary Completion

December 31, 2022

Study Completion

August 1, 2025

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)