Type | Description |
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Inclusion criteria | • Patient with non-inflammatory knee osteoarthritis which is radiologically confirmed and which requires total knee replacement. • Age between 40 and 75 years, inclusive. • Patient plans to be available for follow-up until 2 years post-operative. • Patient is in stable health and is free of or treated for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk. • Patient has < 10° fixed (non-correctable) varus or valgus deformity of the knee. |
Exclusion criteria | • Patient has a BMI > 35. • Patient’s expected physical activity after surgery is 2 or less on the UCLA Activity Scale. • Patient has had previous hip or knee replacement surgery in the last 6 months or is planned to have a (second) hip or knee replacement in the next 6-12 months (because of the effect on function). • Patient has had a previous hip replacement on the affected side (this may cause for a restriction for the rod placement during surgery). • Patient has had major, non-arthroscopic surgery to the study knee, including HTO. • Patient has an active, local infection or systemic infection. • Patient has physical, emotional, or neurological conditions that would compromise compliance with post-operative rehabilitation and follow-up. • Bone stock compromised by disease, infection, or prior implantation which cannot provide adequate support and/or fixation to the prosthesis. • Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function. • Severe instability of the knee joint due to loss of cartilage reported as “substance loss.” • Patient has knee flexion < 90°. • Patient has fixed flexion deformity >10° (passive extension lag). • Patient has >30° 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 quadriceps weakness on the affected side; score on MRC scale < 4. • Patient has rheumatoid arthritis, any auto-immune disorder, or immunosuppressive disorder. |