The Medacta International AMIStem-P Post-Marketing Surveillance Study

N/AActive Not RecruitingNCT04997005

Medacta International SA550 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

550

Conditions

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

Interventions

AMIStem-PDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (5)

Clinique de Saint Omer

Blendecques, France

Hôpital Castres

Castres, France

Nouvelle Clinique Bordeaux Tondu

Floirac, France

Clinique d'Orange

Orange, France

Hôpital Jacques-Puel

Outcomes

Primary Outcomes

Survival rate

Kaplan Meier method

Time frame: 10 years

Secondary Outcomes

Harris Hip Score

Harris Hip Score \[min = 0 (worst clinical outcome), max = 100 (best clinical outcome)\]

Time frame: 3/6 months, 1, 3, 5 and 10 years

Oxford Hip Score

Oxford Hip Score \[min = 0 (worst functional outcome), max = 48 (best functional outcome)\]

Time frame: 3/6 months, 1, 3, 5 and 10 years

Radiographic performance of the implants

Presence of radiolucencies, migration, loosening, subsidence, tilt

Time frame: 3/6 months, 1, 3, 5 and 10 years

Quality of life - Euroqol questionnaire

EQ-5D-5L score \[min = -0.59 (worst functional outcome), max = 1 (best functional outcome)\]

Time frame: 3/6 months, 1, 3, 5 and 10 years

Adverse events

Intraoperative and postoperative adverse events

Time frame: intraop, 3/6 months, 1, 3, 5 and 10 years

Data from ClinicalTrials.gov

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