M-Vizion™ Macroscopic Radiographic Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: revision hip arthroplasty.
- Who it may be relevant to
- Registry conditions: Revision Hip Arthroplasty. Basic parameters: 21 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Medacta M-Vizion™ Macroscopic Radiographic Study, Multi-center, Post-Market Outcomes Study
Overview
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.
Interventions
- Device revision hip arthroplasty
revision hip arthroplasty
Primary outcome measures
- 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)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 7 centers
- Northwestern Medicine — Chicago
- New England Baptist Hospital — Boston
- Beth Israel Deaconess Medical Center — Boston
- Dartmouth Health — Lebanon
- OrthoCarolina Research Institute, Inc. — Charlotte
- Geisinger Medical Center — Danville
- University of Utah Department of Orthopaedics — Salt Lake City
Identifiers
NCT: NCT05721859 · MUSA-H-MV-001