Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT05721859
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT05721859
Study Brief:
Protocol Section:
NCT05721859