RecruitingNCT05721859
M-Vizion™ Macroscopic Radiographic Study
Medacta M-Vizion™ Macroscopic Radiographic Study, Multi-center, Post-Market Outcomes Study
Sponsor
Medacta USA
Enrollment
70 participants
Start Date
Oct 12, 2022
Study Type
OBSERVATIONAL
Conditions
Summary
Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal.
Eligibility
Min Age: 21 YearsMax Age: 80 Years
Inclusion Criteria6
- 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 Criteria5
- 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.
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Interventions
DEVICErevision hip arthroplasty
revision hip arthroplasty
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT05721859