AMIStem-H Radiological Assessment

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03505580

Enrollment

500

Registered

2018-04-23

Start date

2013-10-31

Completion date

2025-08-31

Last updated

2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Replacement Arthroplasty

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Presence of radiolucencies	5 years

Secondary

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

Countries

France

Outcome results