Recruiting

Observational Study

Sponsor:

Medacta USA

Code:

NCT05721859

Conditions

Revision Hip Arthroplasty

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

revision hip arthroplasty

Study Details

Brief summary:

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

Conditions

Revision Hip Arthroplasty

Study ID

NCT05721859

Start date

Oct 12, 2022

Status verified date

May, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Interventions

revision hip arthroplasty

revision hip arthroplasty

Primary outcome measure

  • subsidence [ Time Frame: 6 weeks post-op visit (± 2 weeks) ]
  • subsidence [ Time Frame: 6 Months post-op visit (± 2 months) ]
  • subsidence [ Time Frame: 1 year post-op visit (± 4 months) ]
  • subsidence [ Time Frame: 2 year post-op visit (± 6 months) ]

Central Contacts and Locations

Central contacts

Emily Hord, CCRP

331-208-4284ehord@medacta.us.com

Locations

Northwestern Medicine

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Melissa Shauver

melissa.shauver1@nm.org

Megan VanDyke

megan.vandyke@nm.org

Principal Investigator:

Kevin Hardt, MD

New England Baptist Hospital

Recruiting

Boston, Massachusetts, United States, 02120

Contacts

Michael McTague

617-754-6609mmctague@bidmc.harvard.edu

Principal Investigator:

Eric Smith, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Julia Aguiar

0000000000hjaguiar2@bidmc.harvard.edu

Principal Investigator:

Michael Baratz, MD

Dartmouth Health

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Holly Symonds

holly.b.symonds@hitchcock.org

Principal Investigator:

Wayne Moschetti, MD

OrthoCarolina Research Institute, Inc.

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Alexis Ready

Alexis.Ready@orthocarolina.com

Caleb Michalek

caleb.michalek@orthocarolina.com

Principal Investigator:

Bradley Ellison, MD

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Yagiz Ozdag, MD

0000000000yozdag@geisinger.edu

Principal Investigator:

John Mercuri, MD

University of Utah Department of Orthopaedics

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Brenna Blackburn, PhD, MPH

801-213-7154brenna.blackburn@hsc.utah.edu

Claire Kepron

801-213-7154

Principal Investigator:

Lucas Anderson, MD

More Information

Sponsor

Medacta USA

Last update posted

May 8, 2025

Last verified

May, 2025

Keywords

  • revision
  • hip
  • arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medacta USA on 2025-05-08.