Back to Trials
NCT05721859Recruiting

M-Vizion™ Macroscopic Radiographic Study

Medacta USA

Start Date

10/12/2022

Completion Date

6/1/2026

Summary

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

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.

Eligibility Criteria

Age Range: 21 years to 80 years

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.

Interventions

DEVICE

revision hip arthroplasty

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Revision Hip Arthroplasty

Locations

Northwestern Medicine

Chicago, Illinois 60611

United States

New England Baptist Hospital

Boston, Massachusetts 02120

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Dartmouth Health

Lebanon, New Hampshire 03756

United States

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina 28207

United States

Geisinger Medical Center

Danville, Pennsylvania 17822

United States

University of Utah Department of Orthopaedics

Salt Lake City, Utah 84108

United States