NCT02850575

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
45mo left

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jan 2014Jan 2030

Study Start

First participant enrolled

January 1, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
13.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

16 years

First QC Date

July 22, 2016

Last Update Submit

September 23, 2025

Conditions

Total Hip Replacement

Outcome Measures

Primary Outcomes (1)

  • implant fixation trough IMAGIKA

    implant fixation trough IMAGIKA

    10 years

Secondary Outcomes (6)

  • Harris Hip Score

    preop, 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

    3 months, 5 and 10 years

  • implant stability trough standard x-ray

    3 months, 1, 2, 5, 10 years

  • implant survival trough Kaplan-Meier curve

    3 months, 1, 2, 5, 10 years

  • +1 more secondary outcomes

Interventions

Mpact Double Mobility cupDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients eligible for a total hip replacement at the investigational sites will be invited in the study

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique Générale

Annecy, France, 74000, France

Location

Orthéo - Espace Fauriel

Saint-Etienne, France, 42100, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2016

First Posted

August 1, 2016

Study Start

January 1, 2014

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)