AMIStem-H Radiological Assessment | NCT03505580

Studies
AMIStem-H Radiological Assessment

NCT03505580

Sponsor

Medacta International SA

Status

Terminated

Last Update Posted

Sep 29, 2025Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Hip Replacement Arthroplasty

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

impossibility to carry on the study

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Aug 2025Actual

First Submitted Date

Apr 16, 2018

First Submission Date that Met QC Criteria

Apr 20, 2018

First Posted Date

Apr 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2025

Last Update Posted Date

Sep 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of radiolucencies		5 years

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Paris V		Paris	France	75005	France
Clinique du Cèdre

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided