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Recruiting
NCT05721859
M-Vizion™ Macroscopic Radiographic Study
Conditions: Revision Hip Arthroplasty
Sex: All
Ages: 21 Years – 80 Years
Enrollment: 70
Sponsor: Medacta USA
Location: United States
Summary
Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal.
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.
Source: ClinicalTrials.gov (NCT05721859). StuddyBuddy aggregates publicly available trial information.