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 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT03286868
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic arthritis of the knee indicating primary total knee arthroplasty
* Between the ages of 21 and 80 inclusive
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent
* Varus alignment
Exclusion Criteria:
* Patients less than 21 years of age, or 81 years of age and older
* Unable to provide consent
* BMI \>45
* Pregnancy
* Patients with inflammatory arthritis, posttraumatic osteoarthritis, post high tibial osteotomy, or arthritis due to sepsis will be excluded.
* Active or prior infection
* Medical condition precluding major surgery
* Severe osteoporosis or osteopenia
* Neuromuscular impairment
* Significant co-morbidity affecting ability to ambulate
* Valgus alignment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT03286868
Study Brief:
Protocol Section:
NCT03286868