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 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT03227692
Eligibility Criteria:
Inclusion Criteria:
In order to be eligible to participate in this study, a patient must meet all of the following criteria.
* Knee (either unilateral or bilateral) osteoarthritis (varus deformity only)
* Male or female
* At least 20 years of age
* Patients willing to return for follow-up evaluations.
Study Specific Requirements for Principal Investigator/Site
* Principal Investigator (PI) must have experience of at least 5 TKAs of iASSIST Knee with Persona and Persona conventional instrument system before any study specific activities.
* Site has sufficient resources to take limb CT scanning at 6 months follow-up visit.
Exclusion Criteria:
Absolute contraindications include:
* Knee degenerative diseases other than knee osteoarthritis (such as necrosis/rheumatoid arthritis)
* Too severe OA deformation (FTA: \> 190 degrees/\< 175 degrees)
* Active infection (or within 6 weeks after infection)
* Sepsis
* Osteomyelitis
* Any type of implant is inserted in the affected side of lower extremity
* Hip and/or foot disease on the affected side
Additional contraindications include:
* Uncooperative patient or patient with neurologic disorders who are incapable of following directions
* Diagnosed osteoporosis or osteomalacia
* Metabolic disorders which may impair bone formation
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy or neuromuscular disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT03227692
Study Brief:
Protocol Section:
NCT03227692