A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup

March 20, 2023 updated by: Medacta International SA

A Multi-centre, Prospective Post Marketing Surveillance Study to Assess Mid-term Performance of the Mpact Cup in Subjects Requiring Primary Total Hip Arthroplasty

This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

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

  • United States
    • Colorado
      • Denver, Colorado, United States, 80230
        • Vail Orthopedics, P.C.
    • Idaho
      • Boise, Idaho, United States, 83702
        • Saint Alphonsus Regional Medical Center
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Illinois Bone & Joint Institute, LLC
    • Utah
      • West Jordan, Utah, United States, 84088
        • Jordan Valley Medical Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary total hip arthroplasty

Description

Inclusion Criteria:

  • Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
  • Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use).
  • Patients must be willing to comply with the pre and post-operative evaluation schedule.

Exclusion Criteria:

  • Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study.

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mpact Acetabular Shell
Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.
Device: Mpact Acetabular Shell
Total Hip Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Kaplan-Meier analysis as a measure of implant performance.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The Harris Hip Score.
Time Frame: pre-op, 3/6 months, 1,2 and 5 years
pre-op, 3/6 months, 1,2 and 5 years
Radiological analysis as a meausure of safety.
Time Frame: 3/6 months, 1,2 and 5 years
3/6 months, 1,2 and 5 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 (Actual)

March 1, 2013

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 22, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P01.014.08/00

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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