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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT01475604
Eligibility Criteria:
Inclusion Criteria:
* Age 40 to 80 years
* Primary diagnosis of knee OA
* Appropriate candidate for TKA
* Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects
* Consent to the study and willing to comply with study product and methods including follow-up
Exclusion Criteria:
* Body mass index \> 40 kg/m2
* Scheduled for bilateral TKA
* Advanced hip, spine, or ankle osteoarthritis that significantly limits ambulation
* Subjects who have any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator)
* Use of narcotic pain medication for any condition in the last 1 month prior to surgery
* Self-reported diagnosis of post-traumatic or inflammatory arthritis (e.g. rheumatoid or psoriatic)
* Pregnant or lactating female
* Participation in any clinical trial in the past 30 days
* Vulnerable populations including prisoners and nursing home residents
* Any medical condition that, in the opinion of the investigator, may compromise patient safety or confound the assessment of treatment effectiveness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT01475604
Study Brief:
Protocol Section:
NCT01475604