Knee osteoarthritis
Conditions
Interventions
Experimental group:Total knee arthroplasty using the TiRobot Orthopedic Surgical System
Control group:Surgery using standard total knee arthroplasty instruments
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 - 80, any gender; 2) Knee osteoarthritis patients unresponsive to conservative treatment; 3) Patients assessed by researchers as needing first-time unilateral total knee arthroplasty; 4) Participants fully aware of the study's benefits and risks, and sign the consent form.
Exclusion criteria
Exclusion criteria: Participants in this clinical study must not meet any of the following criteria: 1.BMI>35kg/m^2; 2.Patients with heart,lung,or other vital organ failure; 3.Abnormal liver/kidney function(ALT/AST>1.5×normal,BUN>8.3mmol/L,Scr>115µmol/L); 4.Diabetic patients with poor glycemic control and infection risk per investigator's judgment; 5.Disorders of consciousness or mental illness; 6.History of open knee surgery; 7.Neuromuscular disorders affecting lower limb function; 8.Severe coagulation disorders; 9.Severe internal/surgical diseases or frailty making surgery intolerable; 10.Severe instability not curable by ligament - retaining TKA; 11.Active infection foci(systemic or local); 12.Severe osteoporosis,metabolic bone disease,radiation - induced bone disease,tumor around the knee; 13.Women planning pregnancy,breast - feeding,or pregnant during the study; 14.Participation in other clinical studies within 3 months; 15.Deemed unsuitable for the study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alignment restoration accuracy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Prosthesis implantation precision;Joint function assessment;Surgical time;Total blood loss;Overall machine functionality, stability, and ease-of-use assessment; | — |
Countries
China
Contacts
Public ContactGuoqiang Zhang
Chinese PLA General Hospital
Outcome results
None listed