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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT01844193
Eligibility Criteria:
Inclusion Criteria:
* Patient is a candidate for unilateral primary total knee arthroplasty and has a primary diagnosis of osteoarthritis.
* Patient is a male or non-pregnant female age 18 and older at time of surgery.
* Patient has signed an Institutional review board (IRB)-approved, study-specific informed consent form.
* Patient is willing and able to comply with the postoperative scheduled clinical evaluations and rehabilitation.
Exclusion Criteria:
* Patient has active infection within the affected knee joint.
* Patient requires revision surgery of a previously implanted total knee arthroplasty.
* Patient is morbidly obese, defined as having a body mass index (BMI) greater than or equal to 36.
* Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the intervention.
* Patient has been diagnosed with a systemic disease or current life threatening illness and is not able to carry on normal activities of daily life (e.g. Paget's disease, renal osteodystrophy, etc.).
* Patient has a history of cardiac issues including myocardial infarction and/or has a pacemaker.
* Patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
* Patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
* Patient is a prisoner.
* Patient has indication for contralateral total knee arthroplasty within the evaluation window.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT01844193
Study Brief:
Protocol Section:
NCT01844193