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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT01311804
Eligibility Criteria:
Inclusion Criteria:
* Patients with primary knee osteoarthritis on treatment and planned for unilateral total knee arthroplasty and on spinal/general anesthesia
* Subjects age more than 50 and less than 85 years
* Patients with body weight at least 50 kg and not more than 50%above ideal body weight
* Written informed consent obtained from patient or guardian
Exclusion Criteria:
* Female patients who are attempting to conceive/pregnant
* Known allergy or hypersensitivity to cocktail regime or to COX-2 inhibitors
* History of bleeding disorders or coagulation defect
* Patients with abnormal liver profile
* Patients with history of stroke or major neurological defect
* Patients with neuropathic pain/sensory disorder
* Patients with peptic ulceration or anticoagulant use within 1 month
* History of previous major knee surgery/trauma
* Patients with renal insufficiency
* History of revision total knee arthroplasty
* Patients with knee deformity \> 20 degrees
* Patients planned for bilateral knee arthroplasty during the same setting
* Patients with significant bone loss requiring augmentation
* Patients with history of using NSAIDs 24 hours before the surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT01311804
Study Brief:
Protocol Section:
NCT01311804