M-Vizion™ Macroscopic Radiographic Study
- Conditions
- Revision Hip Arthroplasty
- Registration Number
- NCT05721859
- Lead Sponsor
- Medacta USA
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method subsidence 2 year post-op visit (± 6 months) Occurrence of subsidence \>5mm
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Northwestern Medicine
🇺🇸Chicago, Illinois, United States
New England Baptist Hospital
🇺🇸Boston, Massachusetts, United States
Dartmouth Health
🇺🇸Lebanon, New Hampshire, United States
OrthoCarolina Research Institute, Inc.
🇺🇸Charlotte, North Carolina, United States
University of Utah Department of Orthopaedics
🇺🇸Salt Lake City, Utah, United States