The Medacta International AMIStem-P Post-Marketing Surveillance Study

Active, not recruiting

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

• Registration Number: NCT04997005
• Lead Sponsor: Medacta International SA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-26
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2029-04-30
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 550

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival rate	10 years	Kaplan Meier method

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Nouvelle Clinique Bordeaux Tondu; 🇫🇷 Floirac, France

Clinique de Saint Omer; 🇫🇷 Blendecques, France

Hôpital Castres; 🇫🇷 Castres, France

Hôpital Jacques-Puel; 🇫🇷 Rodez, France

Clinique d'Orange; 🇫🇷 Orange, France