RECRUITING

M-Vizion™ Macroscopic Radiographic Study

Conditions

Revision Hip Arthroplasty revision hip arthroplasty

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-10-12

Study Completion:2025-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05721859

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.

Ages Eligible for Study:21 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Emily Hord, CCRP

CONTACT

331-208-4284

ehord@medacta.us.com

Study Locations (Sites)

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

Collaborators and Investigators

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 Registration Dates

Study Start Date2022-10-12

Study Completion Date2025-06-01

Study Record Updates

Study Start Date2022-10-12

Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

revision
hip
arthroplasty

Additional Relevant MeSH Terms

Revision Hip Arthroplasty