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 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT04916392
Eligibility Criteria:
Inclusion Criteria:
* ASA I-III
* Age 18-80 years old
* Scheduled for elective primary unilateral total knee replacement
* Chinese patients
* BMI \< 40
* Able to speak and understand Cantonese
* Able to provide informed oral and written consent
Exclusion Criteria:
* Single-stage bilateral total knee replacement
* Complex primary total knee replacement requiring the use of stem/augment/constrained liner
* Surgeries with significant intraoperative complications which may alter rehabilitation protocol e.g. collateral ligament injury, fracture requiring fixation
* Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors
* History of chronic pain other than chronic knee pain
* History of immunosuppression
* Daily use of glucocorticoids
* Daily use of strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
* History of severe heart disease (NYHA 2)
* Alcohol or drug abuse
* Impaired renal function, defined as preoperative serum creatinine level over 120 micromol/L
* Pre-existing neurological or muscular disorders
* Psychiatric illness or neurologic or psychiatric diseases potentially influencing pain perception
* Impaired or retarded mental state
* Difficulties in using patient-controlled analgesia (PCA)
* Pregnancy
* Local infection
* On immunosuppressants
* High BMI (\>=40)
* Patient refusal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04916392
Study Brief:
Protocol Section:
NCT04916392