Total knee arthroplasty
Conditions
Interventions
Experimental group vs control group:antibiotic cement produced by Shanghai shangrong biotechnology co., ltd versus Johnson & Johnson cmw cement
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
55 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Female or male aged 55 - 85 years old; 2. because of primary osteoarthritis, rheumatoid arthritis, traumatic arthritis or other knee diseases, the subjects are suitable for unilateral total knee replacement; 3. The subjects can voluntarily and in writing agree to participate in the study and have signed an informed consent form approved by the Ethics Committee; 4. The subjects can understand the clinical research, cooperate with the research procedure, and are willing to go back to the hospital for postoperative follow-up within 24 weeks according to the plan; 5. Body Mass Index (BMI) <=35 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Patients with bilateral knee joint diseases who are expected to have bilateral knee joints replaced during the study (i.e. within the next 24 weeks); 2. It is known that the subjects suffered from diseases (such as tumor, distal femur / proximal tibia osteotomy, severe osteoporosis or metabolic bone disease, etc.) resulting in insufficient bone mass in the femur or tibia to support or fix the prosthesis; 3. Subjects are known or suspected to be allergic to bone cement components; 4. subjects were severely obese (BMI > 35); 5. The subjects expected hip replacement during the study (i.e. within the next 24 weeks); 6. The subject has active infection or septicemia (treated or untreated); 7. the subject suffers from diseases that endanger the stability of the implant or recovery after surgery (e.g., deformity osteositis or neuroarthropathy, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency, or neuromuscular diseases, etc.); 8. Subjects have emotional problems or neurological conditions that may affect their ability or willingness to participate in the study ( e.g., mental illness, mental retardation); 9. The subject is in an immunosuppressive state and suffers from autoimmune diseases or immunosuppressive disorders. For example, patients are using immunosuppressive therapy (high doses of cortisol, cytotoxic drugs, anti-lymphocyte serum, or high doses of radiation) or suffering from acquired immune deficiency syndrome; 10. Pregnant or lactating women or women who plan to become pregnant during the study period; 11. It is known that the subjects are at risk of missing or not returning to the hospital for follow-up according to regulations; 12. The subjects have participated in clinical studies of other drugs, biological agents or devices in the last 6 months; 13. Patients who are known to have excessive drinking or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactXianlong Zhang
Shanghai Sixth People's Hospital
Outcome results
None listed