M-Vizion™ Macroscopic Radiographic Study

May 5, 2025 updated by: Medacta USA

Medacta M-Vizion™ Macroscopic Radiographic Study, Multi-center, Post-Market Outcomes Study

Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the M-Vizion modular stem performance in patients who undergo total hip replacement according to the standard practice. It is expected that subjects receiving revision hip arthroplasty with the Medacta M-Vizion™ modular hip stem will have less than 5mm of stem subsidence at 2 years.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Baratz, MD
      • Boston, Massachusetts, United States, 02120
        • Recruiting
        • New England Baptist Hospital
        • Principal Investigator:
          • Eric Smith, MD
        • Contact:
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • North Carolina
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • John Mercuri, MD
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah Department of Orthopaedics
        • Principal Investigator:
          • Jeremy Gililland, MD
        • Contact:
        • Contact:
          • Claire Kepron
          • Phone Number: 801-213-7154
        • Principal Investigator:
          • Lucas Anderson, MD

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

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients listed for revision THA receiving a M-Vizion femoral component and meeting all inclusion/ exclusion criteria at a research site,

Description

Inclusion Criteria:

  • Must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).
  • Ability to understand and provide written authorization for use and disclosure of personal health information.
  • Subjects who are able and willing to comply with the study protocol and follow-up visits.
  • Patients requiring a revision total hip replacement.
  • Subjects undergoing revision THA who will receive an M-Vizion femoral component according to the indications for use.
  • Male and female patients ages 21 - 80 years of age at the time of surgery.

Exclusion Criteria:

  • Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
  • Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
  • Patients bone stock is compromised by disease or infection, which could possibly prevent adequate support and/or fixation to the prosthesis.
  • Patients with an active or suspected latent infection in or about the hip joint.
  • Patients that are incarcerated.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subsidence
Time Frame: 6 weeks post-op visit (± 2 weeks)
Occurrence of subsidence >5mm
6 weeks post-op visit (± 2 weeks)
subsidence
Time Frame: 6 Months post-op visit (± 2 months)
Occurrence of subsidence >5mm
6 Months post-op visit (± 2 months)
subsidence
Time Frame: 1 year post-op visit (± 4 months)
Occurrence of subsidence >5mm
1 year post-op visit (± 4 months)
subsidence
Time Frame: 2 year post-op visit (± 6 months)
Occurrence of subsidence >5mm
2 year post-op visit (± 6 months)

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 12, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MUSA-H-MV-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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