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 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT02626533
Eligibility Criteria:
Inclusion Criteria:
* Elective primary unilateral total knee arthroplasty
* Osteoarthritis with radiologic evidence of "severe narrowing" and/or "bone on bone" in the affected joint
* Patients of surgeons who have agreed to participate in the study
* Age \> 18 years
* American Society of Anesthesiologists (ASA) Physical Status 1-3
* Regional anesthesia
* Epidural patient-controlled analgesia (PCA) for postoperative pain
* Adductor canal block for postoperative pain
Exclusion Criteria:
* Contraindication to regional anesthesia, NSAIDs, dexamethasone or acetaminophen
* Use of general anesthesia
* History of \>6 weeks of daily opioid use and/or any use of non-prescribed opioids
* Preoperative oral steroid use in the past 6 months
* Intra-articular steroid injection within one month of scheduled surgery in affected joint
* Non-English speakers
* Pre-existing diagnosis of rheumatic disease or autoimmune disease (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type I diabetes)
* Peri-articular injections or infusions for postoperative pain
* Diagnosis of crystalline arthropathy
* Diagnosis of osteonecrosis
* Active infection or use of antibiotics
* Pregnant women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02626533
Study Brief:
Protocol Section:
NCT02626533