Patients with primary osteoarthritis of the knee and overall varus or neutral alignment of the leg.
Conditions
Interventions
Undergoing total knee arthroplasty with or without the addition of a kneecap.
Sponsors
Radboudumc
Eligibility
Inclusion 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. • In stable health (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
Exclusion criteria: Exclusion: • Valgus deformity • 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 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 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 rheumatoid arthritis, any auto-immune disorder, immunosuppressive disorder or a terminal illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in patellar tracking between pre-operative and one year post-operative measured with 4D CT imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Implant positioning: By using the CORI, we will collect implant position, perioperative ligament laxities, alignment and tibiofemoral kinematics. Patient Reported Outcome Measures (PROMs): The following PROMs will be collected; FJS, KOOS and Kujala knee score to assess the patient experienced outcomes in pain and movement before and after the TKA. | — |
Contacts
Public ContactMiriam Boot
Radboudumc
Outcome results
None listed