Bone Fixation of Mpact Double Mobility Cup

September 23, 2025 updated by: Medacta International SA

Etude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte Pour l'évaluation de la Fixation Osseuse d'Une Cupule hémisphérique, le Mpact® Double Mobilité

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • France
      • Annecy, France, France, 74000
        • Clinique Générale
      • Saint-Etienne, France, France, 42100
        • Orthéo - Espace Fauriel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implant fixation trough IMAGIKA
Time Frame: 10 years
implant fixation trough IMAGIKA
10 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medacta International SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

July 22, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimated)

August 1, 2016

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • P01.017.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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