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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT00829556
Eligibility Criteria:
Inclusion Criteria:
1. Subjects who are able and willing to provide informed consent;
2. Male and non-pregnant, non-lactating, female subjects who are willing to practice effective means of contraception or postmenopausal/surgically sterilized female subjects, between the ages of 18-80 years old, of any ethnic origin.
3. Subjects deemed able to comply with study schedule visits, procedures and medications as specified by the protocol.
4. Subjects undergoing elective THA or TKA procedures.
5. Subjects in satisfactory health as determined by the investigator on the basis of medical history and physical examination.
Exclusion Criteria:
1. Subjects undergoing revision, hemiarthroplasty, or bilateral THA or TKA
2. Subjects undergoing non-elective THA or TKA procedures.
3. Pregnant or lactating females or females of childbearing potential not practicing an effective method of contraception.
4. Subjects with known allergies to iodine and/or chlorhexidine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00829556
Study Brief:
Protocol Section:
NCT00829556