M-Vizion™ Macroscopic Radiographic Study
Medacta M-Vizion™ Macroscopic Radiographic Study, Multi-center, Post-Market Outcomes Study
1 other identifier
observational
70
1 country
7
Brief Summary
Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2022
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2022
CompletedFirst Submitted
Initial submission to the registry
January 27, 2023
CompletedFirst Posted
Study publicly available on registry
February 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
May 8, 2025
May 1, 2025
3.6 years
January 27, 2023
May 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
subsidence
Occurrence of subsidence \>5mm
6 weeks post-op visit (± 2 weeks)
subsidence
Occurrence of subsidence \>5mm
6 Months post-op visit (± 2 months)
subsidence
Occurrence of subsidence \>5mm
1 year post-op visit (± 4 months)
subsidence
Occurrence of subsidence \>5mm
2 year post-op visit (± 6 months)
Interventions
revision hip arthroplasty
Eligibility Criteria
Patients listed for revision THA receiving a M-Vizion femoral component and meeting all inclusion/ exclusion criteria at a research site,
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medacta USAlead
Study Sites (7)
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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2023
First Posted
February 10, 2023
Study Start
October 12, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
May 8, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share