The Medacta International AMIStem-P Post-Marketing Surveillance Study

Prospective, Multicentre, Open Study Evaluating the Performance and Stability of the AMIStem-P Femoral Stem

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04997005

Enrollment

550

Registered

2021-08-09

Start date

2019-04-26

Completion date

2032-12-31

Last updated

2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthrosis, Avascular Necrosis of the Femoral Head, Congenital Hip Dysplasia, Rheumatoid Polyarthritis, Traumatic Arthritis

Brief summary

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

Interventions

DEVICEAMIStem-P

Performance of Total Hip Arthroplasty (THA) with AMIStem-P femoral stem implant

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Survival rate	10 years	Kaplan Meier method

Secondary

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026