The Medacta International AMIStem-P Post-Marketing Surveillance Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-26

Study Completion Date

2032-12-31

Brief Summary

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

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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AMIStem-P

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No