Clinical Trials in the USA / NCT05721859
Recruiting
Observational
M-Vizion™ Macroscopic Radiographic Study
NCT05721859 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Revision Hip Arthroplasty
Investigational drug(s) / intervention(s)
revision hip arthroplasty
revision hip arthroplasty: revision hip arthroplasty
Study summary
Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal.
Eligibility
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.
Primary outcome measure(s)
- subsidence — 6 weeks post-op visit (± 2 weeks)
Occurrence of subsidence \>5mm - subsidence — 6 Months post-op visit (± 2 months)
Occurrence of subsidence \>5mm - subsidence — 1 year post-op visit (± 4 months)
Occurrence of subsidence \>5mm - subsidence — 2 year post-op visit (± 6 months)
Occurrence of subsidence \>5mm
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Northwestern Medicine | Chicago | Illinois | Recruiting |
| New England Baptist Hospital | Boston | Massachusetts | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | Recruiting |
| Dartmouth Health | Lebanon | New Hampshire | Recruiting |
| OrthoCarolina Research Institute, Inc. | Charlotte | North Carolina | Recruiting |
| Geisinger Medical Center | Danville | Pennsylvania | Recruiting |
| University of Utah Department of Orthopaedics | Salt Lake City | Utah | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05721859 on ClinicalTrials.gov ↗ ← All trials in the USA