Osteoarthritis of knee joint
Conditions
Interventions
Intervention group:Experienced senior doctors plan surgeries, and middle-aged doctors perform robot assisted total knee arthroplasty under the supervision of senior doct
Control group:The same experienced senior doctor planned and performed robot assisted total knee arthroplasty
Sponsors
Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Male or female subjects, aged 40-80 years (inclusive); 2.The subject was suitable for primary knee arthroplasty due to primary osteoarthritis, rheumatoid arthritis, traumatic arthritis, etc; 3.The subjects were able to give their voluntary and written consent to participate in the study, and signed the informed consent approved by the ethics committee; 4.The subjects can understand the clinical study, cooperate with the research procedures, and are willing to return to the hospital for postoperative follow-up within 12 months after surgery according to the protocol;
Exclusion criteria
Exclusion criteria: 1.Subject is known or suspected to be allergic to metals; 2.It is known that the subjects are unable to support and / or fix the prosthesis due to insufficient bone mass in the femur or tibia due to diseases (such as tumor, severe osteoporosis, metabolic bone disease, etc.); 3.The subject suffered from diseases that would endanger the stability of the implant or the recovery after surgery (such as Neuroarthropathy, moderate or severe muscle dysfunction of the lower limb on the operated side, etc.); 4.Subjects have emotional problems or neurological conditions that may affect their ability or willingness to participate in the study (such as mental illness, mental retardation); 5.Pregnant or lactating women or women planning to become pregnant during the study; 6.The subject is known to be at risk of losing follow-up or not returning to the hospital for follow-up as required; 7.The subject has participated in clinical research of other drugs, biological agents or devices in the last 12 months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate of 1-year postoperative follow-up; | — |
Secondary
| Measure | Time frame |
|---|---|
| Osteotomy angle, KSS score, WOMAC score;Surgical complications and adverse events;Postoperative imaging assessment: Full-length X-ray film of the lower extremities, full-length CT of the lower extremities, and upright upright film of the knee joint;Postoperative hematological examination: blood routine, urine routine, biochemical (liver function, kidney function), inflammatory indicators; | — |
Countries
China
Contacts
Public ContactZhai Zanjing
Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine
Outcome results
None listed