Medacta M-Vizion™ Macroscopic Radiographic Study, Multi-center, Post-Market Outcomes Study
Medacta USA
Summary
Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal.
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.
Eligibility
- Age range
- 21–80 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Devicerevision hip arthroplasty
revision hip arthroplasty
Locations (7)
- Northwestern MedicineChicago, Illinois
- New England Baptist HospitalBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dartmouth HealthLebanon, New Hampshire
- OrthoCarolina Research Institute, Inc.Charlotte, North Carolina
- Geisinger Medical CenterDanville, Pennsylvania