Assess the Mid-term Performance of the Mpact Cup in Subjects Requiring Total Hip Arthroplasty

June 15, 2023 updated by: Medacta USA

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

Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

187

Phase

  • Not Applicable

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
      • Parker, Colorado, United States, 80134
        • Denver Vail Orthopedics
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Medical Group
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Illinois Bone And Joint Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • McBride Orthopedic Hospital
    • Utah
      • West Jordan, Utah, United States, 84088
        • Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence

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

Yes

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mpact cup
Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head
Device: MPact Cup
Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Harris Hip Scores (HHS)
Time Frame: Pre-operative, 3 or 6 months, 1 year, 2 year and 5 year
Assessment of improvement of clinical outcomes following total hip replacement surgery using the Harris Hip Scores
Pre-operative, 3 or 6 months, 1 year, 2 year and 5 year
Change from baseline of implant survivorship
Time Frame: Post-operative 3 or 6 months, 1 year, 2 year, and 5 year
Assessment of bone fracture, implant fracture, neck reabsorption
Post-operative 3 or 6 months, 1 year, 2 year, and 5 year
Change in baseline of Complications
Time Frame: Day of surgery, post-operative 3 or 6 months, 1 year, 2 year, and 5 year.
Assessment of Adverse events and serious adverse events
Day of surgery, post-operative 3 or 6 months, 1 year, 2 year, and 5 year.
Change in baseline fixation and wear
Time Frame: Post-operative 3 or 6 months, 1 year, 2 year and 5 year
Radiographic analysis by measuring Radio Lucent Lines
Post-operative 3 or 6 months, 1 year, 2 year and 5 year
Change in baseline fixation
Time Frame: Post-operative 3 or 6 months, 1 year, 2 year and 5 year
Radiographic analysis by measuring implant fixation in millimeters
Post-operative 3 or 6 months, 1 year, 2 year and 5 year

Collaborators and Investigators

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

Sponsor

Medacta USA

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)

October 1, 2012

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 28, 2019

First Posted (Actual)

April 1, 2019

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P01.014.08/01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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