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AMIStem-H Radiological Assessment

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ClinicalTrials.gov Identifier: NCT03505580
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Medacta International SA

Brief Summary:

The purpose of this study is to evaluate radiological performance of the cementless femoral stem AMIStem H at 1 and 5-year follow-up.

All the patients operated at the investigational sites between April 2009 and April 2012 will be reviewed at 1, 5 and 10 year according to standard practice


Condition or disease
Hip Replacement Arthroplasty

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Etude rétrospective et Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la sécurité de l'Implant AMIStem
Study Start Date : October 2013
Actual Primary Completion Date : December 31, 2017
Estimated Study Completion Date : April 30, 2022



Primary Outcome Measures :
  1. Presence of radiolucencies [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. correlation between the presence of radiolucencies and patient/implant characteristics [ Time Frame: 5 years, 10 years ]
  2. evaluation of radiolucent lines progression [ Time Frame: 1 years, 10 years ]
  3. evaluation of radiolucent lines progression [ Time Frame: 5 years, 10 years ]
  4. Record of adverse events [ Time Frame: 1, 5 years and 10 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All the patients who undewent total hip arthroplasty with AMIStem-H cementless femoral stem at the investigational sites between April 2009 and April 2012
Criteria

Inclusion Criteria:

  • patients who underwent total hip arthroplasty at the investigational sites between April 2009 and April 2012
  • patients bearing an AMIStem-H cementless femoral stem

Exclusion Criteria:

  • patients who refuse to give consent for the treatment of data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505580


Locations
France
Clinique du Cèdre Recruiting
Bois Guillaume, France, 76230
Contact: Pascal Viè    +33 2 35 59 59 59      
Clinique Paris V Recruiting
Paris, France, 75005
Contact: Frederic Laude    +33 826 30 75 05      
Sponsors and Collaborators
Medacta International SA

Responsible Party: Medacta International SA
ClinicalTrials.gov Identifier: NCT03505580     History of Changes
Other Study ID Numbers: P01.001.07
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018