M-Vizion™ Macroscopic Radiographic Study

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Description

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

Targeted Conditions

Study Overview

Start Date
October 12, 2022
Completion Date
June 1, 2025
Enrollment
70
Date Posted
February 10, 2023
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Northwestern Medicine
Chicago, Illinois 60611, United States

New England Baptist Hospital
Boston, Massachusetts 02120, United States

Dartmouth Health
Lebanon, New Hampshire 03756, United States

OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina 28207, United States

University of Utah Department of Orthopaedics
Salt Lake City, Utah 84108, United States

Eligibility

Study Population
Patients listed for revision THA receiving a M-Vizion femoral component and meeting all inclusion/ exclusion criteria at a research site,
Minimum Age (years)
21
Maximum Age (years)
80
Eligibility Criteria
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 Contact Info

Study Contact Name
Emily Hord, CCRP
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
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.
NCTid (if applicable)
NCT05721859