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:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT04732000
Eligibility Criteria:
Inclusion Criteria:
1. Over 18
2. Male of female
3. Planning to undergo primary total hip arthroplasty
4. Fluent in English
5. Willing and able to sign an informed consent form and HIPAA authorization and to comply with study procedures
Exclusion Criteria:
1. Infectious disease within the last month
2. Immune-suppressant therapy within the last 2 months (e.g., azathioprine or cyclosporine)
3. Chronic medication with potential immune-modulatory effects (e.g., daily oral morphine-equivalent intake \> 30 mg)
4. Major surgery within the last 3 months or minor surgery within the last month.
5. History of substance abuse (e.g., alcoholism, drug dependency)
6. Pregnancy
7. Autoimmune disease interfering with data interpretation (e.g. lupus)
8. Renal, hepatic, cardiovascular, or respiratory diseases resulting in clinically relevant impaired function
9. Active malignancy
10. Participation in another clinical trial of an investigational drug or device within the last month that, in the investigator's opinion, would create an increased risk to the participant or compromise the integrity of the study
11. Other conditions compromising a participant's safety or the integrity of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04732000
Study Brief:
Protocol Section:
NCT04732000