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 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT04502459
Eligibility Criteria:
Inclusion Criteria:
1. Patients suffer from primary osteoarthritis indicated for total knee arthroplasty
2. Subject is physically and mentally willing and able to comply with the postoperative scheduled clinical and radiographic evaluations
3. Subject must have signed an informed consent document specific to the study, and approved by the Ethics Committee, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
1. Subject requires a revision knee arthroplasty surgery
2. Subject is currently on anti-coagulant therapy or has coagulopathy
3. Subject has peripheral vascular disease of the lower limb evidenced by the presence of blood vessel calcification on the radiographs or the absence of dorsalis pedis/popliteal pulses
4. Subject suffers from conditions other than primary knee osteoarthritis, e.g. inflammatory arthritis
5. Subject having associated medical diseases affecting rehabilitation
6. Subject has active systemic infection or infection near the knee joint
7. Subject having current medical condition that render them unfit for surgery
8. Any criterion which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04502459
Study Brief:
Protocol Section:
NCT04502459