Bone Fixation of Mpact Double Mobility Cup

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02850575

Enrollment

150

Registered

2016-08-01

Start date

2014-01-31

Completion date

2030-01-31

Last updated

2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Hip Replacement

Brief summary

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

Interventions

DEVICEMpact Double Mobility cup

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
implant fixation trough IMAGIKA	10 years	implant fixation trough IMAGIKA

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026