Osteoarthritis of the knee Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with medial and lateral compartment osteoarthritis of the knee with intact cruciate ligaments 2. Patients willing and able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with osteoarthritis limited to one compartment of the knee 2. Patients with rheumatoid arthritis 3. Patients with medial or lateral subluxation of the tibia on the femur 4. Patients with a varus or valgus deformity greater than 15º 5. Patients with a flexion contracture greater than 10º 6. Patients with rupture of either the ACL or PCL 7. Active or recent local infection 8. Patello-femoral OA greater than Kellgren and Lawrence grade III 9. Patients who have had previous surgery to the knee which may impact on the outcome of TKA or bi-unicompartmental knee arthroplasty 10. Patients with significant disease in other joints which might impact on their gait 11. Patients unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with a bi-phasic (normal) moment curve during gait (level walking) measured at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biomechanical performance: Gait during stair climb/descent and lunge, functional activity assessment (using electrogoniometers) at 1 year 2. Activity: Overall daily activity levels, maximum sport/physical activity, functional activity test times (stair climb, timed up and go) 1,2,5 and 10 years 3. Impairment: Range of motion, proprioception, quadriceps strength (short term outcome) and progression of OA in contralateral knee (long term outcome) at 1,2,5 and 10 years 4. Clinical Outcomes: Clinical knee scores (Oxford Knee Score and American Knee Society Score), pain, analgesic use, complications, implant fixation and satisfaction at 1,2,5 and 10 years 5. Safety profile: Determined by revision rate, adverse events, robotic system errors and accuracy of implantation at 1,2,5 and 10 years 6. Accuracy of surgical implantation, determined by post-op CT analysis, at 1 year | — |
Countries
Scotland, United Kingdom