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
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
The inclusion criteria are:
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. Vulnerable persons according to article L1121-6 of the Public Health Code
5. Pregnant or breastfeeding women
6. Patients unable to formulate their non-opposition
7. Patient refusing collection of personal data
Primary outcome measure(s)
Assess the femoral stem migration — 2 years The primary endpoint is the measurement of femoral component migration by EBRA-FCA software (The Ein Bild Roentgen Analyse-femoral component analysis, Innsbruck, Austria) with an accuracy of ± 1.5 mm (95% percentile), a specificity of 100% and a sensitivity of 78% for the detection of a migration of more than 1.0 mm, referring to the RSA method. The EBRA-FCA method is based on the detection of 19 points on the bony femur and the femoral component, as well as two lines to determine the axis of the implant on successive radiographs of the front pelvis. The correction of the radiological enlargement is performed based on the known diameter of the prosthetic femoral component. Lengths are measured from anatomical reference points to ensure comparability of the radiographs. The change in the distance between the top of the greater trochanter and the shoulder of the prosthesis is used to measure the migration of the femoral component.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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