Bone Fixation of Mpact Double Mobility Cup

Total Hip Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02850575
• Other study ID #: P01.017.01
• Status: Active, not recruiting
• Start date: January 2014
• Est. completion date: January 2030

Study information

• Verified date: October 2023
• Source: Medacta International SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Hip Replacement

Intervention

Device:
• Mpact Double Mobility cup

Locations

Country	Name	City	State
France	Clinique Générale	Annecy
France	Orthéo - Espace Fauriel	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

France, 

Outcome

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