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 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT03683992
Eligibility Criteria:
Inclusion Criteria:
* Patients who qualify for a cementless primary total knee arthroplasty\*
* 18 years of age but no more than 75 years of age
* Willing to be randomized
* Willing to sign informed consent
* Willing to return for all follow-up visits
Exclusion Criteria:
* Patients with inflammatory arthritis
* BMI equal to 40 or less.
* Patient with an active infection or suspected infection in the operative joint
* The absolute and relative contraindications stated in the FDA cleared labeling for the device
* Patients who have undergone osteotomy
* Patients who have had previous patella fracture or surgery
* Patients who have had previous healed tibia or femur fractures
* Patients who have had previous knee or hip replacement surgery on the ipsilateral side
* Patients who require patellar resurfacing
* Patients with major medical/muscular/orthopedic deformities
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03683992
Study Brief:
Protocol Section:
NCT03683992