The Medacta International AMIStem-P Post-Marketing Surveillance Study

May 5, 2025 updated by: Medacta International SA

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Blendecques, France, 62575
        • Clinique de Saint Omer
      • Castres, France, 81108
        • Hôpital Castres
      • Floirac, France, 33270
        • Nouvelle Clinique Bordeaux Tondu
      • Orange, France, 84100
        • Clinique d'Orange
      • Rodez, France, 12000
        • Hôpital Jacques-Puel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients requiring Total Hip Arthroplasty and who are suitable to receive Medacta AMIStem-P femoral stem will be proposed to take part to the current post-market surveillance study during their pre-operative visit.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: 10 years
Kaplan Meier method
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic performance of the implants
Time Frame: 3/6 months, 1, 3, 5 and 10 years
Presence of radiolucencies, migration, loosening, subsidence, tilt
3/6 months, 1, 3, 5 and 10 years
Adverse events
Time Frame: intraop, 3/6 months, 1, 3, 5 and 10 years
Intraoperative and postoperative adverse events
intraop, 3/6 months, 1, 3, 5 and 10 years
Harris Hip Score
Time Frame: 3/6 months, 1, 3, 5 and 10 years
Harris Hip Score [min = 0 (worst clinical outcome), max = 100 (best clinical outcome)]
3/6 months, 1, 3, 5 and 10 years
Oxford Hip Score
Time Frame: 3/6 months, 1, 3, 5 and 10 years
Oxford Hip Score [min = 0 (worst functional outcome), max = 48 (best functional outcome)]
3/6 months, 1, 3, 5 and 10 years
Quality of life - Euroqol questionnaire
Time Frame: 3/6 months, 1, 3, 5 and 10 years
EQ-5D-5L score [min = -0.59 (worst functional outcome), max = 1 (best functional outcome)]
3/6 months, 1, 3, 5 and 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medacta International SA

Investigators

  • Principal Investigator: Alexandru Nebunescu-Schirliu, MD, Hôpital Jacques-Puel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2019

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P01.001.16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthrosis

Clinical Trials on AMIStem-P

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe