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:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT01514318
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have received the Revelation™ Hip Stem as part of a total hip arthroplasty prior to 2002.
* Surgery must have been a primary total hip replacement
* Subject must have received only one primary hip replacement per hospitalization
* Subject must have had a diagnosis of inflammatory tissue disorder, osteoarthritis, post-traumatic arthritis/secondary arthritis or avascular necrosis
* Subject must be willing and able to sign the informed consent document
Exclusion Criteria:
* Subject must not have had any previous hip implants (hemi or total joint)
* Subject has a mental condition that may interfere with the ability to give an informed consent (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Subject is a prisoner
* Subject is pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01514318
Study Brief:
Protocol Section:
NCT01514318