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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT01305733
Eligibility Criteria:
Inclusion Criteria:
* Patients requiring primary TKA for primary OA
* Patients aged 75 years or less
* Patients suitable for all applicable devices
Exclusion Criteria:
* Rheumatoid arthritis or other inflammatory diseases
* Patients requiring bone grafting during surgery
* Unwilling to provide informed consent
* BMI \> 35
* ASA \> 3
* Renal dysfunction
* Allergic to ASA
* Previous high tibial osteotomy or previous osteosynthesis
* \> 15 degrees varus / valgus malalignment
* Physical, emotional or neurological conditions which would comprise the patient´s compliance with postoperative rehabilitation and follow-up (e.g. drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson, MS, etc.)
* Known sensitivity to materials in the devices
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01305733
Study Brief:
Protocol Section:
NCT01305733