Diseases of knee joints
Conditions
Interventions
Robot-assisted mobile-bearing unicompartmental joint replacement group:To perform unicompartmental joint replacement by robot
Conventional mobile-bearing unicompartmental arthroplasty group:To performed unicompartmental joint replacement by traditional surgical methods
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged from 18 to 75 years old; 2. Skeletal maturity; 3. The subjects should have the indication of unicompartmental knee arthroplasty. 4. Before surgery, the subjects were willing and able to sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. The subject has neuromuscular dysfunction (e.g., paralysis, myolysis, or abductor weakness); 2. The subject is mentally incapable or unable to understand the requirements of participating in the study; 3. Alcoholics or drug addicts or drug abusers; 4. Obesity BMI > 35; 5. Poorly controlled diabetes mellitus (fasting plasma glucose >=8.0mmol/L after drug control); 6. Severe liver and kidney dysfunction; 7. The subject is known to have a history of allergy to one or more of the implanted materials; 8. Active infection of knee joint or other body parts; 9. Severe osteoporosis, metabolic bone disease, radiation bone disease and tumor around the knee joint; 10. Pregnant or lactating women or those planning to become pregnant within 12 months; 11. Systemic diseases (including coagulopathy, severe heart disease, severe respiratory disease, others can not tolerate anesthesia or surgery); The life expectancy of those who are weak or cannot tolerate surgery due to other systemic diseases is less than 2 years. 12. Participants who had participated in clinical trials of other drugs, biological agents or medical devices before enrollment and did not meet the primary endpoint time limit; 13. The other combined diseases of the subjects limited their participation in the study and could not comply with the follow-up, which affected the scientific integrity of the study. 14. Subjects do not cooperate with or are not conducive to the treatment and postoperative rehabilitation exercise, and the compliance is expected to be poor; 15. Subjects had a history of knee surgery; 16. Other circumstances considered by the investigator to be inappropriate for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Planned valance angle of the femoral prosthesis;The measured value of the femoral prosthesis angulation outward;Planned flexion angle of the femoral prosthesis;Measured value of the femoral prosthesis flexion angle;Planned value of the tibial prosthesis varus angle;The measured value of the tibial prosthesis varus angle;Planned value of the posterior inclination angle of the tibial prosthesis;The measured value of the posterior inclination angle of the tibial prosthesis;Planned values for internal and external rotation of the tibial prosthesis;The measured values of internal and external rotation of the tibial prosthesis;Preoperative planning of the femoral prosthesis model;The actual model of the femoral prosthesis after the operation;Preoperative planning of the type of tibial prosthesis;The actual model of the tibial prosthesis after the operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale, VAS;Knee Society Score;Postoperative Knee Range of Motion; | — |
Countries
China
Contacts
Public ContactNan Shaokui
Chinese PLA General Hospital
Outcome results
None listed