EBRA Study AMISTEM-C FR

Medacta

Status: Active, not recruiting

Conditions: Total Hip Arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT05848024

P01.001.10

Details and patient eligibility

About

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

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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