Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05721859

M-Vizion™ Macroscopic Radiographic Study

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern Medicine, Chicago, Illinois, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

revision hip arthroplasty

Device

revision hip arthroplasty

Primary outcomes

  1. subsidence

    Time frame: 6 weeks post-op visit (± 2 weeks)

    Occurrence of subsidence >5mm

  2. subsidence

    Time frame: 6 Months post-op visit (± 2 months)

    Occurrence of subsidence >5mm

  3. subsidence

    Time frame: 1 year post-op visit (± 4 months)

    Occurrence of subsidence >5mm

  4. subsidence

    Time frame: 2 year post-op visit (± 6 months)

    Occurrence of subsidence >5mm

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Hord, CCRP

CONTACT

[email protected]

331-208-4284

Sponsors and collaborators

Lead sponsor

Medacta USA

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2023
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.