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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT02760459
Eligibility Criteria:
Inclusion Criteria:
* Age \> 40 years (45)
* Primary knee osteoarthritis diagnosed using the American College of Rheumatology criteria (46)
* Undergoing elective, primary and unilateral total knee arthroplasty
* American Society of Anesthesiology (ASA) physical status class 1-3
* BMI \< 40 kg/m2
Exclusion Criteria:
* History of active rheumatic diseases
* History of previous musculoskeletal injury of the same knee for excluding patients with secondary knee osteoarthritis
* History of previous surgery on the same knee
* History of adverse effects from medications to be used in this study
* Contraindication to spinal anesthesia
* History of psychiatric disorders or cognitive impairment
* Contraindication to corticosteroid agents
* Poorly controlled diabetes mellitus (HbA1C \> 7.5)
* Poorly controlled hypertension
* History of ischemic heart disease or peripheral arterial disease or cerebrovascular disease
* Hepatic insufficiency (Child-Pugh score \> 5)
* Renal insufficiency (Creatinine clearance \< 30 mL/min)
* History of cataracts or glaucoma or ocular hypertension
* History of steroid or immunosuppressive drug use within 6 months of surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02760459
Study Brief:
Protocol Section:
NCT02760459