Osteoarthritis of knee
Conditions
Interventions
experimental group:TKA with RIO
control group:Manual TKA
Sponsors
Orthopedic Department of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Indicated for total knee arthroplasty, with invalid conservative therapies; 2. Aged over 45 years; 3. Body mass index no more than 35 kg/m2; 4. Skeletal mature adult, who can tolerate surgical intervention and participate further follow-ups; 5. Primary total knee arthroplasty; 6. Not participated in other clinical trial(s) within 12 months previously.
Exclusion criteria
Exclusion criteria: 1. The candidate is not able to provide informed consent(s) in written form; 2. Pregnancy or in lactation period; 3. Scheduled contralateral total knee arthroplasty in 12 months after the index procedure; 4. Participating this study of contralateral knee; 5. Prior surgical procedures, including partial knee replacement (unicondylar knee arthroplasty, bicondylar knee arthroplasty, or patellofemoral resurfacing), patella resection, high tibial osteotomy, or total knee arthroplasty; 6. Advanced malignancies, dyscrasia, addict to alcohol or drugs, and/or mental dysfunctions, which the researcher considered inappropriate for inclusion; 7. Severe osteoporosis, metabolic bone diseases, radiative bone diseases or malignancy around the knee, which the researcher considered to have adverse effect on fixation or results of the study; 8. 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.); 9. Inability for communication, reading, or understanding, and unable to accomplish the subjective questionnaire for participants; 10. Life expectancy less than 2 years; 11. Comorbidity which limits the candidate from participating the study; 12. Participating in other drug or instrumental trial; 13. Allergic to implanted component(s) (e. g. metal); 14. Hemoglobin level less than 11g/dl; 15. Hypoalbuminemia (level of alumin < 90% of lower limit of normal); 16. Elevated C-reactive protein (2 times over higher limit of normal); 17. Elevated erythrocyte sedimentation rate (2 times over higher limit of normal); 18. Coagulation disorders (unable to correct or substitute); 19. Other conditions which the researcher considered inappropriate for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Femorotibial angle;Survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| KSS Score;Oxford Knee Score;SF-12;WOMAC Score;Radiologic Evaluation; | — |
Countries
China
Contacts
Public ContactChai Wei
Chinese PLA General Hospital
Outcome results
None listed