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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT05824533
Eligibility Criteria:
Inclusion Criteria:
* Non-inflammatory knee osteoarthritis, which is confirmed by radiology.
* Osteoarthritis is unilateral or bilateral with the contralateral knee functioning properly, not operated on in the last 6 months.
* Set to receive a primary cemented total knee arthroplasty.
* Aged between 50 and 80 years, inclusive, on the day of the operation.
* This age limit of 50 is based on the desire to include exclusively patients with primary osteoarthritis. As osteoarthritis is an age-related disorder, it generally involves adults over the age of 50 years. Patients under the age of 50 years who present with osteoarthritis usually have osteoarthritis due to a secondary cause (e.g. post-traumatic osteoarthritis).
* A maximum age of 80 years will be employed. This age limit will be adopted because patients should be well able to perform an extension-flexion movement while a dynamic CT scan is made.
* In stable health (American Society of Anesthesiology (ASA)-score ≤ 3) and is free of or treated for cardiac, pulmonary, haematological, or other conditions that would pose excessive operative risk.
* Patient has a correctable or \<10° rigid (non-correctable) varus deformity of the knee.
* Participants must be able to give informed consent.
* Patient plans to be available for follow-up until two years post-operative.
* Ability to walk for 2 minutes without walking aid
Exclusion Criteria:
* Valgus deformity
* Body MAss Index (BMI) \> 35.
* Previous hip /knee/ankle replacement surgery in the last 12 months, or is planned to have a hip replacement in the next 6-12 months.
* Patient has had major, non-arthroscopic surgery to the study knee, including High Tibial Osteotomy (HTO).
* Patient has an active, local infection or systemic infection
* Incomplete or insufficient tissue surrounding the knee.
* Severe damage to the medial or collateral knee ligaments and popliteal tendon
* Documented osteoporosis with patient in active medical treatment.
* Patient has physical, emotional or neurological conditions that impacts gait or balance, or would compromise compliance with post-operative rehabilitation and follow-up.
* Bone quality compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis
* Knee flexion \< 90 degrees
* \> 30 degrees extension deficit (active restraint to extension)
* Patient does not have a proper functioning patella tendon on the affected side; measured as inability of active extension of the knee
* Patient has active rheumatoid arthritis, any auto-immune disorder, immunosuppressive disorder or a terminal illness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT05824533
Study Brief:
Protocol Section:
NCT05824533