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Clinical Trials/NCT04997005
NCT04997005
Active, not recruiting
Not Applicable

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

Medacta International SA5 sites in 1 country550 target enrollmentApril 26, 2019
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ConditionsArthrosisTraumatic ArthritisRheumatoid PolyarthritisCongenital Hip DysplasiaAvascular Necrosis of the Femoral Head

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthrosis
Sponsor
Medacta International SA
Enrollment
550
Locations
5
Primary Endpoint
Survival rate
Status
Active, not recruiting
Last Updated
11 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
April 26, 2019
End Date
December 31, 2032
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Survival rate

Time Frame: 10 years

Kaplan Meier method

Secondary Outcomes

  • Harris Hip Score(3/6 months, 1, 3, 5 and 10 years)
  • Oxford Hip Score(3/6 months, 1, 3, 5 and 10 years)
  • Radiographic performance of the implants(3/6 months, 1, 3, 5 and 10 years)
  • Quality of life - Euroqol questionnaire(3/6 months, 1, 3, 5 and 10 years)
  • Adverse events(intraop, 3/6 months, 1, 3, 5 and 10 years)

Study Sites (5)

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