M-Vizion™ Macroscopic Radiographic Study
Recruiting now
Conditions studied: Revision Hip Arthroplasty
In brief
Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal.
Key facts
- Study ID
- NCT05721859
- Run by
- Medacta USA
- People needed
- 70
- Starts
- 2022-10-12
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-05-08
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Northwestern Medicine — Chicago, Illinois, United States (enrolling)
- New England Baptist Hospital — Boston, Massachusetts, United States (enrolling)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
- Dartmouth Health — Lebanon, New Hampshire, United States (enrolling)
- OrthoCarolina Research Institute, Inc. — Charlotte, North Carolina, United States (enrolling)
- Geisinger Medical Center — Danville, Pennsylvania, United States (enrolling)
- University of Utah Department of Orthopaedics — Salt Lake City, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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