Bone Fixation of Mpact Double Mobility Cup

Active, not recruiting

• Conditions: Total Hip Replacement

• Registration Number: NCT02850575
• Lead Sponsor: Medacta International SA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Primary Completion: 2030-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
implant fixation trough IMAGIKA	10 years	implant fixation trough IMAGIKA

Secondary Outcome Measures

Name	Time	Method
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
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
Harris Hip Score	preop, 3 months, 1, 2, 5, 10 years	Harris Hip Score

Trial Locations

Locations (2)

Clinique Générale; 🇫🇷 Annecy, France

Orthéo - Espace Fauriel; 🇫🇷 Saint Etienne, France