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Trial record 4 of 12 for:    MPACT

Bone Fixation of Mpact Double Mobility Cup

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ClinicalTrials.gov Identifier: NCT02850575
Recruitment Status : Recruiting
First Posted : August 1, 2016
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Medacta International SA

Brief Summary:
This study aims to evaluate long term fixation of the Mpact Double Mobility cup trough IMAGIKA technology.

Condition or disease Intervention/treatment
Total Hip Replacement Device: Mpact Double Mobility cup

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Etude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte Pour l'évaluation de la Fixation Osseuse d'Une Cupule hémisphérique, le Mpact® Double Mobilité
Study Start Date : January 2014
Estimated Primary Completion Date : January 2029
Estimated Study Completion Date : January 2029



Primary Outcome Measures :
  1. implant fixation trough IMAGIKA [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Harris Hip Score [ Time Frame: preop, 3 months, 1, 2, 5, 10 years ]
  2. complications [ Time Frame: intraop, immediate postop, 3 months, 1, 2, 5, 10 years ]
  3. penetration of femoral head in the polyethylene insert trough IMAGIKA [ Time Frame: 3 months, 5 and 10 years ]
  4. implant stability trough standard x-ray [ Time Frame: 3 months, 1, 2, 5, 10 years ]
  5. implant survival trough Kaplan-Meier curve [ Time Frame: 3 months, 1, 2, 5, 10 years ]
  6. implant fixation trough IMAGIKA [ Time Frame: 3 months and 5 years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients eligible for a total hip replacement at the investigational sites will be invited in the study
Criteria

Inclusion Criteria:

  • primary hip replacement
  • patients 18 to 80 years old
  • patients who accept the follow-up schedule

Exclusion Criteria:

  • femoral neck fracture
  • patients requiring grafts
  • progressive local or systemic infections
  • patients presenting muscular deficiency, neuromuscular disease or vascular insufficiency of the involved limb
  • patients suffering from diseases that can compromize the recovery to independent mobility
  • patients with BMI > 40
  • patients with cognitive diseases that can compromize their participation in the study
  • patients living in geographical area not allowing the clinical follow-up to be performed
  • patients participating in other biomedical research
  • patients <18 years old
  • patients > 80 years old
  • pregnant or breast feeding women

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): NCT02850575


Contacts
Contact: Mara Colombo +41 91 696 60 60 colombo@medacta.ch

Locations
France
Clinique Générale Recruiting
Annecy, France, 74000
Contact: Christophe Fornasieri    04 50 33 09 50      
Orthéo - Espace Fauriel Recruiting
Saint Etienne, France, 42100
Contact: François Chalencon    04 77 42 09 82      
Sponsors and Collaborators
Medacta International SA

Responsible Party: Medacta International SA
ClinicalTrials.gov Identifier: NCT02850575     History of Changes
Other Study ID Numbers: P01.017.01
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018