The Medacta International AMIStem-P Post-Marketing Surveillance Study

Medacta

Status: Active, not recruiting

Conditions: Traumatic Arthritis; Rheumatoid Polyarthritis; Avascular Necrosis of the Femoral Head; Congenital Hip Dysplasia; Arthrosis

Treatments: Device: AMIStem-P

Study type: Observational

Funder types: Industry

Identifiers

NCT04997005

P01.001.16

Details and patient eligibility

About

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

Enrollment: 550 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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