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NCT Number: NCT02850575

Bone Fixation of Mpact Double Mobility Cup

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Total Hip Replacement

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Générale, Annecy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mpact Double Mobility cup

Device

Primary outcomes

  1. implant fixation trough IMAGIKA

    Time frame: 10 years

    implant fixation trough IMAGIKA

Secondary outcomes

  1. Harris Hip Score

    Time frame: preop, 3 months, 1, 2, 5, 10 years

    Harris Hip Score

  2. complications

    Time frame: intraop, immediate postop, 3 months, 1, 2, 5, 10 years

    complications

  3. 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

  4. implant stability trough standard x-ray

    Time frame: 3 months, 1, 2, 5, 10 years

    implant stability trough standard x-ray

  5. implant survival trough Kaplan-Meier curve

    Time frame: 3 months, 1, 2, 5, 10 years

    implant survival trough Kaplan-Meier curve

  6. implant fixation trough IMAGIKA

    Time frame: 3 months and 5 years

    implant fixation trough IMAGIKA

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2030
Study completion
2030
First posted
Aug 1, 2016
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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