Mpact Cup Performance After Total Hip Arthroplasty

Suspended

• Conditions: Total Hip Replacement

• Registration Number: NCT02846636
• Lead Sponsor: Medacta International SA

Brief Summary

The main objective of this study is to evaluate the 10 year performances of Mpact cup in total hip arthroplasty.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23
• Primary Completion: 2029-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients requiring a total hip replacement who meets the standard indications for use for Medacta implants
• patients who accept to participate in the study
• patients who signed the consent form for the treatment of personal data

Exclusion Criteria

• patients presenting conditions identified as contraindication for Medacta implants
• revision surgeries

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
implant survival trough Kaplan-Meier curve	10 years

Secondary Outcome Measures

Name	Time	Method
implant stability trough assessment of presence of radiolucencies	3/6 months, 1, 3, 5, 7, 10 years
record of adverse events	intraop, 3/6 months, 1, 3, 5, 7, 10 years
hip function with Harris Hip Score	preop, 3/6 months, 1, 3, 5, 7, 10 years

Trial Locations

Locations (1)

Clinique Médico-Chirurgicale Paris V; 🇫🇷 Paris, France