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The Medacta International AMIStem-P Post-Marketing Surveillance Study | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

The Medacta International AMIStem-P Post-Marketing Surveillance Study

Prospective, Multicentre, Open Study Evaluating the Performance and Stability of the AMIStem-P Femoral Stem

NCT04997005•Medacta International SA

View on ClinicalTrials.gov

Summary

This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head, etc.) requiring a total hip replacement
•Patient eligible to receive an uncemented AMIStem-P femoral stem
•Patient agreeing to comply with the study requirements
•Patient willing to provide written informed consent
•Patient affiliated to a social security system
•Patients between 18 and 85 years old

Exclusion Criteria

•Participation in biomedical research
•Patients younger than 18 years old
•Vulnerable adult patients according to article L1121-6 of the French Public Health Code
•Pregnant or breastfeeding women
•Patients unable to provide written informed consent

Locations (5)

Clinique de Saint Omer

Blendecques, France

Hôpital Castres

Castres, France

Nouvelle Clinique Bordeaux Tondu

Floirac, France

Clinique d'Orange

Orange, France

Hôpital Jacques-Puel

Rodez, France

Key Dates

Start Date

April 26, 2019

Primary Completion Date

April 30, 2029

Completion Date

December 31, 2032

Last Updated

May 8, 2025

Enrollment

550

ESTIMATED participants

Conditions

ArthrosisTraumatic ArthritisRheumatoid PolyarthritisCongenital Hip DysplasiaAvascular Necrosis of the Femoral Head

Interventions

AMIStem-P

DEVICE

A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System

NCT07118501

Post Traumatic ArthritisOsteoarthritis+2 more

View study

RECRUITINGNA

Control Cohort CTRL COH

NCT05370079

Parkinson's Disease; Amyotrophic Lateral Sclerosis; Glioblastoma; Cancer Without Neurological Disease; Rheumatoid Polyarthritis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The Medacta International AMIStem-P Post-Marketing Surveillance Study

Inclusion Criteria

Exclusion Criteria

A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System

Control Cohort CTRL COH

Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)

The Use of Stromal Vascular Fraction for Knee Arthrosis

Collecting Bone Graft During Spinal Decompression and Posterolateral Lumbar Fusion to Better Define Bone Making Cells

Descriptive Single-center Retrospective Study of a Series of Cases of Clavicle Pseudarthrosis: Epidemiology, Surgical Management, and Functional Outcomes