EBRA Study AMISTEM-C FR

Prospective, Single-Center, Non-Controlled, Non-Randomized, Open Study Evaluating the Performance and Stability of Amistem® C

NCT05848024•Medacta International SA

View on ClinicalTrials.gov

Summary

Primary objective: Evaluate femoral stem migration Secondary objective: Evaluate the performance of AMIStem H Proximal Coating at 10 years after surgery; assessment of functional recovery; radiological evaluation; reporting of complications Scores collected: HHS, OHS, PMA, UCLA

Detailed Description

The main objective of the study was to evaluate the migration and performance of the AMIStem® C femoral stem at 10 years follow-up. The primary endpoint is the measurement of femoral component migration by EBRA-FCA (The Ein Bild Roentgen Analyse-femoral component analysis, Innsbruck, Austria) The secondary objectives of the study are: Evaluate the performance of the AMIStem® C stem Evaluate the function of the operated hip To evaluate the quality of life To evaluate the safety of the AMIStem® C femoral stem Evaluate the postoperative stability and fixation of the hip prosthesis

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head...) requiring the placement of a total hip prosthesis.
•2. Patient who will receive an AMIStem® C cemented femoral stem.
•3. Patient willing to comply with the study requirements
•4. Patient who has signed the information letter agreeing to the processing of their data in the clinical evaluation
•5. Patient affiliated to a social security system
•6. Patients aged 18 to 85 years
•The criteria for non-inclusion are:
•1. Participation in biomedical research
•2. Minor patients
•3. Protected adult patients
+4 more criteria

Locations (1)

Hôpital privé Arras Les Bonnettes

Arras, France

Key Dates

Start Date

February 8, 2017

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2029

Last Updated

September 29, 2025

Enrollment

100

ACTUAL participants

Conditions

Total Hip Arthroplasty

Molecular Mechanisms Underlying Hip and Knee Osteoarthritis in Patients Undergoing Primary Elective Arthroplasty

NCT07347821

Total Hip Arthroplasty (THA)Total Knee Arthroplasty (TKA)+2 more

View study

RECRUITINGNA

Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty

NCT07337642

Primary Total Hip Arthroplasty

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: September 29, 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.

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EBRA Study AMISTEM-C FR

Inclusion Criteria

Molecular Mechanisms Underlying Hip and Knee Osteoarthritis in Patients Undergoing Primary Elective Arthroplasty

Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty

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