Osteoarthritis
Conditions
Interventions
Experimental group:Experienced senior doctors plan surgeries, and middle-aged doctors perform robot assisted total knee arthroplasty under the supervision of senior doctors.
Control group:Planning and execution were carried out by the same experienced senior physician.
Sponsors
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: (a) Male or female participants, aged 40-80 years (inclusive); (b) The subject is suitable for initial knee replacement surgery due to primary osteoarthritis, rheumatoid arthritis, traumatic arthritis, etc; (c) The subjects voluntarily and in writing agree to participate in the study and have signed an informed consent form approved by the ethics committee; (d) The subjects are able to understand the clinical study, cooperate with the research procedures, and are willing to return to the hospital for postoperative follow-up within 12 months according to the protocol.
Exclusion criteria
Exclusion criteria: (a) The subject is known or suspected to be allergic to metals; (b) It is known that the subject has insufficient bone mass in the femur or tibia due to diseases such as tumors, severe osteoporosis, metabolic bone disease, etc., which makes it impossible to support and/or fix the prosthesis; (c) The subject suffers from diseases that may endanger the stability of the implant or postoperative recovery (such as neuroarthritis, moderate to severe muscle dysfunction in the lower limb on the surgical side, etc.); (d) The subjects may have emotional problems or neurological conditions that may affect their ability or willingness to participate in the study (such as mental illness, mental retardation); (e) Pregnant or lactating women or women planning to become pregnant during the study period; (f) It is known that there is a risk of the subject being lost to follow-up or not returning to the hospital for follow-up according to regulations; (g) The subject has participated in clinical studies of other drugs, biologics, or devices within the past 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate; | — |
Countries
China
Contacts
Public ContactZanjing Zhai
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed