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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT01320150
Eligibility Criteria:
Inclusion Criteria:
* undergoing standard tricompartmental TKR;
* 18 to 85 yrs of age;
* patient has a diagnosis of osteoarthritis
* knee to be replaced is the primary source of patient's pain;
* patient agrees to preoperative and follow-up visits and to comply with the assessment tests;
* patient consents to standard anesthetic and analgesic protocol, with medical care as deemed necessary by the anesthesiologist, and has no contraindications.
Exclusion Criteria:
* chronic opioid use ≥ 10 mg/day of morphine equivalents within one wk prior to the surgery, and duration of use \> 4 wks;
* history of opioid abuse;
* inability to understand and communicate with the investigators to complete the study related questionnaires
* patient currently enrolled in another study;
* patient is planning to undergo another elective joint replacement procedure during the 6-mo period of participation;
* any co-morbidity which results in severe systemic disease limiting function {as defined by the American Society of Anesthesiology (ASA) physical status classification \> 3}
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01320150
Study Brief:
Protocol Section:
NCT01320150