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 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT05693818
Eligibility Criteria:
Inclusion Criteria:
* • Patient must be 18 years of age or older
* Independent of study participation, patient is indicated for a commercially available PIQ TKA implant in accordance with product labeling
* Patient must be willing and able to complete the protocol required follow-up
* Patient has participated in the study-related informed consent process
* Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved informed consent
Exclusion Criteria:
* • Simultaneous bilateral TKA
* Staged bilateral TKA less than 6 months from indexed procedure
* Patient is a current alcohol or drug abuser
* Patient is known to be pregnant, breastfeeding, or considered a member of a protected class (e.g., prisoner, mentally incompetent, etc.)
* Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent and participation in follow-up program
* Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
* Patient with Neuropathic Arthropathy
* Patient with any loss of musculature or neuromuscular disease that compromises the affected limb
* Patients with known symptomatic foot, hip or spinal injuries and/or conditions that could affect gait
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05693818
Study Brief:
Protocol Section:
NCT05693818