Bilateral Medial Knee Osteoarthritis
Conditions
Interventions
Perform UKA first
Perform TKA first
Sponsors
Zimmer K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1). Patient is 20 to 70 years of age at the Informed Consent (IC), inclusive 2). Both males and females 3). Patient qualifies for bilateral primary medial UKA due to bilateral unicompartmental knee osteoarthritis (Do not want to randomly implant a UKA in a patient who requires TKA) 4). Patient has more than 120 degree pre-op Range of Motion (ROM) 5). Patient expect load bearing ROM to be less than or equal to 155 degrees 6). Patient with flexion contracture less than 15 degree 7). Patient with preserved lateral compartment and patellofemoral joint 8). Patient with varus deformity less than 15 degree (Valgus deformities will be excluded from this study) 9). Patient with not significant obesity defined with a Body Mass Index (BMI) of <40 10). Patient has no osteophyte in intercondylar notch 11). Patient has intact anterior cruciate ligaments 12). Patient is willing and able to provide the written IC by signing and dating the Independent Ethics Committee (IEC) approved IC form 13). Patient is willing and able to complete scheduled study procedures and follow-up evaluations 14). Japanese
Exclusion criteria
Exclusion criteria: 1). Patient is currently participating in any other surgical intervention studies or pain management studies 2). Patient with previous history of infection in the affected joint and/or local/systemic infection that may affect the prosthetic joint 3). Patient with insufficient bone stock on femoral or tibial surfaces 4). Patient with skeletal immaturity 5). Patient with neuropathic arthropathy 6). Patient with chondrocalcinosis 7). Patient with osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb 8). Patient with damage to the articular cartilage of the opposite compartment 9). Patient with inflammatory synovitis 10). Patient with eburnation in the patellofemoral joint 11). Patient with a stable, painless arthrodesis in a satisfactory functional position 12). Patient with severe instability secondary to the absence of collateral ligament integrity 13). Patient with an ulcer of the skin or a history of recurrent breakdown of the skin 14). Patient with history of deep vein thrombosis (DVT) or pulmonary embolism (PE) 15). Patient has a known or suspected sensitivity or allergy to one or more of the implant materials 16). Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2011 Knee Society Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic Assessment, Clinical Assessments and Safety Assessment | — |
Countries
Japan
Contacts
Public ContactAkira Kashima
Zimmer K.K. Clinical Affairs
Outcome results
None listed