The Medacta International AMIStem-P Post-Marketing Surveillance Study

NCT04997005 — Active not recruiting, 550 participants, Medacta International SA

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

RegistryNCT04997005
StatusActive not recruiting
Study typeObservational
Enrollment550 (Estimated)
SponsorMedacta International SA (Industry)
ConditionsArthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis, Congenital Hip Dysplasia, Avascular Necrosis of the Femoral Head
InterventionsAMIStem-P (Device)
Datesstart 2019-04-26, primary completion 2029-04-30 (estimated), completion 2032-12-31 (estimated), first posted 2021-08-09, last updated 2025-05-08
Locations5 sites in France

Related Papers Related Patents Related Grants Related Experts
All trials for Arthrosis All trials for Traumatic Arthritis All trials of AMIStem-P

-Summary

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

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+Arms and interventions

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

+Outcome measures

Primary outcomes

  • Survival rate [10 years]: Kaplan Meier method

Secondary outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to 85 Years

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)

FacilityCityCountryStatus
Clinique de Saint OmerBlendecquesFrance
Hôpital CastresCastresFrance
Nouvelle Clinique Bordeaux TonduFloiracFrance
Clinique d'OrangeOrangeFrance
Hôpital Jacques-PuelRodezFrance

+Investigators