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 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT06040827
Eligibility Criteria:
Inclusion
* Patient must be 18 years of age or older
* Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to osteoarthritis, limited to:
* Mild or Moderate valgus, varus, or flexion deformities
* Patient must be willing and able to complete the protocol required follow-up
* Patient is indicated for a 58mm or 30mm tibial stem extension
* 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
* Patient has a platform-compatible personal computer located in their dwelling with appropriate wireless internet access and a USB port
* Independent of study participation, patient is a candidate for commercially available Persona Personalized Knee System implanted in accordance with product labeling
Exclusion
* 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 has previous history of infection in the affected joint and/or a local or systemic infection that may affect the prosthetic joint
* Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
* Patient with skeletal immaturity
* Patient has insufficient bone stock on femoral or tibial surfaces
* Patient with Neuropathic Arthropathy
* Patient has osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb
* Patient has severe instability secondary to the absence of collateral ligament integrity.
* Patient has a stable, painless arthrodesis in a satisfactory functional position
* Patient has rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
* Patient has a known or suspected sensitivity to one or more of the implant materials
* Patient is undergoing procedures or treatments using ionizing radiation
* Patients with known symptomatic foot, hip, or spinal injuries and/or conditions that could affect gait
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06040827
Study Brief:
Protocol Section:
NCT06040827