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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT07080892
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 80 years
* Patients undergoing primary unilateral total knee arthroplasty (TKA) for osteoarthritis
* Ability to understand and sign informed consent
* American Society of Anesthesiologists (ASA) classification I-III
* Ability to cooperate and participate in postoperative pain assessments (e.g., VAS)
Exclusion Criteria:
* Refusal to participate or failure to sign informed consent
* Bilateral or revision TKA
* Partial or unicondylar knee replacement
* Severe knee deformity (flexion, varus, or valgus \>30°)
* Diagnosis other than osteoarthritis (e.g., rheumatoid arthritis, septic arthritis, post-traumatic arthritis)
* Allergy to local anesthetics or any medications used in the study
* Contraindications to regional anesthesia (e.g., infection at the injection site, coagulopathy, therapeutic anticoagulation)
* BMI \> 40 kg/m²
* Severe renal impairment (KDIGO stage G4 or higher) or liver failure (Child-Pugh score ≥ 10)
* Prior surgery or vascular procedure on the femoral vessels of the operated limb
* Language barrier or inability to assess pain using the VAS
* Planned outpatient (same-day discharge) procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07080892
Study Brief:
Protocol Section:
NCT07080892