Bone Fixation of Mpact Double Mobility Cup

NCT ID: NCT02850575

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2030-01-31

Brief Summary

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

Detailed Description

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Conditions

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Total Hip Replacement

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Mpact Double Mobility cup

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medacta International SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Générale

Annecy, France, France

Site Status

Orthéo - Espace Fauriel

Saint-Etienne, France, France

Site Status

Countries

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France

Other Identifiers

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P01.017.01

Identifier Type: -

Identifier Source: org_study_id

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