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

Medacta International SA2 sites in 1 country500 target enrollmentOctober 1, 2013

ConditionsHip Replacement Arthroplasty

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hip Replacement Arthroplasty
Sponsor: Medacta International SA
Enrollment: 500
Locations: 2
Primary Endpoint: Presence of radiolucencies
Status: Terminated
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 1, 2013

End Date

August 1, 2025

Last Updated

7 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medacta International SA

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Presence of radiolucencies

Time Frame: 5 years

Secondary Outcomes

evaluation of radiolucent lines progression(5 years, 10 years)
Record of adverse events(1, 5 years and 10 years)
correlation between the presence of radiolucencies and patient/implant characteristics(5 years, 10 years)