AMIStem-H Radiological Assessment

Hip Replacement Arthroplasty Clinical Trial

Official title:

Etude rétrospective et Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la sécurité de l'Implant AMIStem

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03505580
• Other study ID #: P01.001.07
• Status: Active, not recruiting
• Start date: October 2013
• Est. completion date: April 2024

Study information

• Verified date: March 2023
• Source: Medacta International SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: April 2024
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients who underwent total hip arthroplasty at the investigational sites between April 2009 and April 2012

• patients bearing an AMIStem-H cementless femoral stem

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hip Replacement Arthroplasty

Locations

Country	Name	City	State
France	Clinique du Cèdre	Bois Guillaume
France	Clinique Paris V	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of radiolucencies		5 years
Secondary	correlation between the presence of radiolucencies and patient/implant characteristics		5 years, 10 years
Secondary	evaluation of radiolucent lines progression		1 years, 10 years
Secondary	evaluation of radiolucent lines progression		5 years, 10 years
Secondary	Record of adverse events		1, 5 years and 10 years