Osteoarthritis or acute bone infarction of knee
Conditions
Interventions
experimental group:UKA with RIO
control group:Manual UKA
Sponsors
Orthopedic Department of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Indicated for unicompartmental knee arthroplasty, including anteriolateral compartment osteoarthritis and acute focal infarction, with invalid conservative therapy; 2. Aged between 45 and 75 years; 3. Body mass index <= 35kg/m2; 4. Skeletal mature adult, who can tolerate surgical intervention and participate further follow-ups; 5. Primary partial knee arthroplasty; 6. Not participated in other clinical trial(s) within 12 months previously; 7. Written Informed Consent provided.
Exclusion criteria
Exclusion criteria: 1. Unilateral hip arthroplasty within 12 months previously, or scheduled contralateral knee arthroplasty within 12 months after index surgical procedure; 2. Osteoarthritis of lateral compartment and/or lateral patellofemoral joint with subluxation; fixed flexion contracture or varus over 10 degrees; subluxation over 5 mm; 3. Inflammatory arthritis; 4. Allergic to any component(s) of implant; 5. Osteopenia due to known comorbidity (e. g. tumor, severe osteoporosis, metabolic or radioactive bone disease), difficulties in implant support or fixation; 6. Acute or chronic local or systematic infection; 7. Pregnancy or lactation period; 8. Participating this study of contralateral knee; 9. Prior surgical procedures, including patella surgeries, patella resection, or high tibial osteotomy; 10. Advanced malignancies, dyscrasia, addict to alcohol or drugs, and/or mental dysfunctions, which the researcher considered inappropriate for inclusion; 11. Severe dysfunction in nervous system or musculoskeletal system, which may have adverse effect on gait or weight bearing (e. g. muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcots disease, etc.); 12. Inability for communication, reading, or understanding, and unable to accomplish the subjective questionnaire for participants; 13. Life expectancy less than 2 years; 14. Comorbidity which limits the candidate from participating the study; 15. Participating in other drug or instrumental trial; 16. Hemoglobin level less than 11g/dl; 17. Hypoalbuminemia (level of alumin < 90% of lower limit of normal); 18. Elevated C-reactive protein (2 times over higher limit of normal); 19. Elevated erythrocyte sedimentation rate (2 times over higher limit of normal); 20. Coagulation disorders (unable to correct or substitute); 21. Other conditions which the researcher considered inappropriate for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HSS Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oxford Knee Score;SF-12;WOMAC Index;Radiological evaluation;Survival rate; | — |
Countries
China
Contacts
Public ContactChai Wei
Chinese PLA General Hospital
Outcome results
None listed