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 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT05788757
Eligibility Criteria:
Inclusion Criteria:
* Patient is indicated for knee replacement, or has already undergone knee replacement, with a device manufactured or distributed by Exactech
* Patient is skeletally mature
* Patient meets the indications detailed in the applicable product package insert Patient is willing and able to review and sign an informed consent form, if necessary
Exclusion Criteria:
* Patient has a local or systemic infection
* Patient has a known sensitivity to one or more of the materials in the knee replacement system to be used
* Patient is pregnant
* Patient has a mental or physical condition that may invalidate evaluation of the data - ---
* Patient is a prisoner
* Surgery is contraindicated according to the applicable product package insert
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05788757
Study Brief:
Protocol Section:
NCT05788757