The Medacta International AMIStem-P Post-Marketing Surveillance Study

Sponsor

Medacta International SA (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04997005

Collaborator

(none)

550

Enrollment

Locations

164.2

Anticipated Duration (Months)

110

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Arthrosis Traumatic Arthritis Rheumatoid Polyarthritis Congenital Hip Dysplasia Avascular Necrosis of the Femoral Head	Device: AMIStem-P

Study Design

Study Type:

Observational

Anticipated Enrollment :

550 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 26, 2019

Anticipated Primary Completion Date :

Apr 30, 2029

Anticipated Study Completion Date :

Dec 31, 2032

Outcome Measures

Primary Outcome Measures

Survival rate [10 years]
Kaplan Meier method

Secondary Outcome Measures

Clinical outcome [3/6 months, 1, 3, 5 and 10 years]
Harris Hip Score
Functional outcome [3/6 months, 1, 3, 5 and 10 years]
Oxford Hip Score
Radiographic performance of the implants [3/6 months, 1, 3, 5 and 10 years]
Presence of radiolucencies, migration, loosening, subsidence, tilt
Quality of life [3/6 months, 1, 3, 5 and 10 years]
EQ-5D score
Adverse events [intraop, 3/6 months, 1, 3, 5 and 10 years]
Intraoperative and postoperative adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique de Saint Omer	Blendecques	France	62575
2	Hôpital Castres	Castres	France	81108
3	Nouvelle Clinique Bordeaux Tondu	Floirac	France	33270
4	Clinique d'Orange	Orange	France	84100
5	Hôpital Jacques-Puel	Rodez	France	12000