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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT00793234
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients aged \> 18 and \< 80 years old
* Female patients should be post menopausal
* Patients undergoing primary elective total knee replacement surgery
* Written informed consent obtained from the patient (or a legally acceptable representative) prior to inclusion in the study
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Exclusion Criteria:
* Body weight \< 50 kg or \> 100 kg
* Patients undergoing a hemiarthroplasty, surface repair or revisionary surgery of the knee
* Confirmed symptomatic deep vein thrombosis or pulmonary embolism within the past year
* Anticipated use of indwelling intrathecal or epidural catheter for more than 4 h after surgery or during the entire study
* Uncontrolled hypertension (SBP\>160 mm Hg or DBP \> 100 mm Hg)
* History of intracranial or intraocular bleeding. History of gastrointestinal and/or endoscopically verified ulcer disease within the past year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00793234
Study Brief:
Protocol Section:
NCT00793234