Rheumatoid arthritis/Osteoarthritis of the knee
Conditions
Interventions
Experimental group:PEEK knee prosthesis
Control group:Smith & Nephew knee prosthesis
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 50-80 years, and the gender is not limited. Young subjects should have urgent needs for surgery; 2. The subject's bones are mature; 3. The subject has indications for total knee replacement, such as: non-inflammatory degenerative joint disease (such as osteoarthritis, traumatic arthritis or avascular necrosis); inflammatory degenerative joint disease (including rheumatoid arthritis); correction of functional deformities; 4. The affected limb on the test side is the first to receive total knee replacement; 5. Before surgery, subjects or guardians are willing and able to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with neuromuscular insufficiency (eg: paralysis, myolysis or muscle weakness) can cause postoperative knee instability or abnormal gait; 2. The patient is mentally incapable or unable to understand the requirements of participating in the research; 3. Alcoholic or drug addicts, drug abusers; 4. Poor compliance is expected; 5. Obesity: BMI > 35; 6. The patient is known to have a history of allergies to one or more implanted materials; 7. Active infection in the knee joint or other parts of the body; 8. Severe osteoporosis, metabolic bone disease, radiation bone disease, tumor around the knee joint; 9. Pregnant or lactating women; 10. Those who are physically weak or cannot tolerate surgery due to other diseases in the body; 11. Patients with lower extremity venous thrombosis on the operation side; 12. Other diseases combined with the subjects restrict their participation in the research, cannot comply with the follow-up or affect the scientific integrity of the research; 13. Patients who have participated in clinical studies of other drugs, biological agents or medical devices before being selected and failed to reach the primary study endpoint; 14. Other circumstances that the investigator considers unsuitable to participate in this clinical trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Success rate of postoperative imaging implantation;Prosthesis survival;Incidence of adverse events in total knee arthroplasty; | — |
Primary
| Measure | Time frame |
|---|---|
| KSS score''excellent rate''; | — |
Countries
China
Contacts
Public ContactJiang Qing
Nanjing Drum Tower Hospital
Outcome results
None listed