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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT04592302
Eligibility Criteria:
Inclusion criteria:
1. Primary elective total joint arthroplasty patients undergoing surgery with a Rothman Institute arthroplasty surgeon.
2. Participant is a current smoker.
3. Diagnosis of osteoarthritis, inflammatory arthritis, and post-traumatic arthritis.
Exclusions criteria:
1. Age \< 18
2. Revision surgery
3. Prior infection in hip or knee at the surgical site
4. BMI \>40 (It is currently the standard of care in our practice to require patients to have a BMI \< 40 due to an increased risk of infection. This will not represent a change in practice.)
5. Diabetics with Hgb A1C \>8 (It is currently the standard of care in our practice to require patients to have a Hgb A1C \<8 due to an increased risk of infection. This will not represent a change in practice.)
6. Patients using chewing tobacco, cigars, or other form of oral tobacco product
7. Patients using e-cigarettes or vaporizers
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04592302
Study Brief:
Protocol Section:
NCT04592302