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 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT05434260
Eligibility Criteria:
Inclusion Criteria:
1. Patient ≥18 years old
2. Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
3. Subjects scheduled to undergo total knee or total hip revision for aseptic reasons (per 2018 ICM criteria 5)
4. Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. Subjects not willing to sign consent form to be randomized must be willing to sign alternate consent form to allow prospective data collection in the non-randomized arm of the study
Exclusion Criteria:
1. Subjects with known allergies to iodine or any other ingredients in Surgiphor
2. Subjects unwilling to sign informed consent
3. Subjects, for health reasons or other, in the opinion of the Investigator, with a life expectancy less than one year, which is the follow-up period of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05434260
Study Brief:
Protocol Section:
NCT05434260