NCT05721859 M-Vizion™ Macroscopic Radiographic Study
| NCT ID | NCT05721859 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medacta USA |
| Condition | Revision Hip Arthroplasty |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2022-10-12 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2022-10-12 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05721859 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Revision Hip Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05721859 currently recruiting?
Yes, NCT05721859 is actively recruiting participants. Contact the research team at ehord@medacta.us.com for enrollment information.
Where is the NCT05721859 trial being conducted?
This trial is being conducted at Chicago, United States, Boston, United States, Boston, United States, Lebanon, United States and 3 additional locations.
Who is sponsoring the NCT05721859 clinical trial?
NCT05721859 is sponsored by Medacta USA. The trial plans to enroll 70 participants.