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 @ 5:21 PM
Ignite Modification Date:
2025-12-24 @ 5:21 PM
NCT ID:
NCT06460350
Eligibility Criteria:
Inclusion Criteria:
* \>18 years of age
* Scheduled for elective primary unilateral TKA
* T-score \< 60 on the PROMIS Anxiety measure
Exclusion Criteria:
* Children (\<18 yr.)
* Pregnant women
* Active alcoholism (defined as daily use of more than 1 liter of wine and /or 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs)
* Severe chronic pain condition that requires daily preoperative opioid dependence
* T-score ≥ 60 in any of the three PROMIS measures (i.e., sleep, anxiety, and depression)
* Other concomitant surgery being performed in addition to TKA
* Patients undergoing bilateral TKA
* Patients undergoing knee replacement revision
* Patients with limited mobility (in a wheelchair or requiring a walker)
* Patients who are not returning home after surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06460350
Study Brief:
Protocol Section:
NCT06460350