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 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 12:46 AM
NCT ID:
NCT07191067
Eligibility Criteria:
Inclusion Criteria:
1. Male or non-pregnant females age ≥ 21 years of age;
2. Has an underlying diagnosis of osteoarthritis indicated for a primary unilateral TKA according to established treatment guidelines;
3. Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI);
4. Able and willing to comply with all trial tests, procedures, assessments, and follow-up visits for up to 45 days.
5. Able to read and understand instructions and information presented in English.
Exclusion Criteria:
1. Chronic opioid use (average ≥ 30 oral morphine equivalents / day) ≤ thirty (30) days of the TKA procedure;
2. Extended-release or long-acting opioid (e.g. buprenorphine, Morphine ER, etc.) use ≤ thirty (30) days of the TKA procedure;
3. History of substance abuse or misuse;
4. History of significant cardiac disease (e.g. ejection fraction ≤ 50%; coronary intervention ≤ six (6) months; significant valvular abnormalities);
5. Prior radiofrequency ablation or cryotherapy for pain on the operative knee;
6. Prior TKA on the operative knee;
7. BMI \> 40;
8. History of neurological, neuromuscular or neuropathic disease that would confound the study results, including chronic pain conditions;
9. Have an active implanted biomedical device (such as cardiac pacemaker, insulin pump, pain stimulator, implantable cardioverter defibrillator) or cochlear \[ear\] stimulator);
10. History of hip or knee dislocation or bone fractures on the operative leg;
11. Sepsis or systemic infectious illness; local infection of skin or subcutaneous tissues where procedural access is required including thigh, hip or groin;
12. Concomitant medical or psychiatric illness that could compromise evaluation or treatment, including anxiety (GAD-7 score \>10) or depression (PHQ-9 score \>15);
13. Pregnant, actively planning a pregnancy or breast-feeding a child;
14. Uncontrolled diabetes (A1C \> 7.5%);
15. History of bleeding disorder;
16. Participating in another clinical trial/investigation within 45 days prior to signing informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT07191067
Study Brief:
Protocol Section:
NCT07191067