M-Vizion™ Macroscopic Radiographic Study

Last updated: May 5, 2025
Sponsor: Medacta USA
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

revision hip arthroplasty

Clinical Study ID

NCT05721859
MUSA-H-MV-001
  • Ages 21-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must be able to read, understand, and provide written informed consent on theInstitutional Review Board (IRB) approved Informed Consent Form (ICF).

  • Ability to understand and provide written authorization for use and disclosure ofpersonal health information.

  • Subjects who are able and willing to comply with the study protocol and follow-upvisits.

  • Patients requiring a revision total hip replacement.

  • Subjects undergoing revision THA who will receive an M-Vizion femoral componentaccording to the indications for use.

  • Male and female patients ages 21 - 80 years of age at the time of surgery.

Exclusion

Exclusion Criteria:

  • Patients with neuromuscular or neurosensory deficiency, which would limit theability to assess the performance of the device.

  • Patients with a systemic or metabolic disorder leading to progressive bonedeterioration.

  • Patients bone stock is compromised by disease or infection, which could possiblyprevent 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 Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: revision hip arthroplasty
Phase:
Study Start date:
October 12, 2022
Estimated Completion Date:
June 01, 2026

Study 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.

Connect with a study center

  • Northwestern Medicine

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • New England Baptist Hospital

    Boston, Massachusetts 02120
    United States

    Active - Recruiting

  • Dartmouth Health

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • OrthoCarolina Research Institute, Inc.

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Rothman Orthopaedic Institute

    Bryn Mawr, Pennsylvania 19010
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Active - Recruiting

  • Rothman Orthopaedic Institute

    Malvern, Pennsylvania 19335
    United States

    Site Not Available

  • University of Utah Department of Orthopaedics

    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

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