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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT03970460
Eligibility Criteria:
Inclusion Criteria:
* Tricompartmental osteoarthritis of the knee
* Age, under 60 years old at the time of surgery
* Stable health (the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history).
Exclusion Criteria:
* Diagnosis of inflammatory joint disease
* Diagnosis of osteonecrosis
* Infection; acute or chronic
* Any current metal hardware on the proximal 25 cm of the tibia
* History, remote or recent, of high tibial osteotomy or tibial plateau fracture
* Any collateral ligamentous instability in the affected knee
* Contra lateral below knee or above knee amputation
* Ongoing Biphosphonate pharmacotherapy
* Presence of clinically significant disease of the cardiovascular, renal, hepatic, hematologic,respiratory, endocrine, neurological, gastrointestinal, genitourinary, immune systems or other medical condition which is not well controlled.
* Participants of a study who have received an investigational drug or device within the last 30 days
* Patients unwilling or unable to cooperate in a follow-up program
* Bone deficit (subchondral cyst)
* Previous contralateral Total Knee Arthroplasty (TKA), ORIF, HTO
* Patella deficiency needing grafting or preventing patella resurfacing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
59 Years
Study:
NCT03970460
Study Brief:
Protocol Section:
NCT03970460