Mpact Cup Performance After Total Hip Arthroplasty

October 18, 2023 updated by: Medacta International SA

Prospective, Multicentric, Non-controlled, Non-randomized Clinical Survey to Evaluate Mpact Cup Performance After Total Hip Arthroplasty

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

Study Overview

Status

Suspended

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75007
        • Clinique Médico-Chirurgicale Paris V

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients eligible for total hip arthroplasty who meet the inclusion criteria will be invited in the study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
implant survival trough Kaplan-Meier curve
Time Frame: 10 years
10 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medacta International SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

July 22, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (Estimated)

July 27, 2016

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • P01.014.07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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