periprosthetic knee infection
Conditions
Interventions
Antibiotic composite bone cement group:Gentamicin-containing composite bone cement is used to fix all knee joint prostheses in total knee arthroplasty.
Composite Bone Cement without Antibiotics group:In total knee arthroplasty, bone cement without any antibiotics is used to fix all knee prostheses.
Sponsors
First Affiliated Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, gender unrestricted; 2. Meets the diagnostic criteria for knee osteoarthritis; 3. Meets the indications for total knee arthroplasty and undergoes total knee arthroplasty; 4. Voluntary participation with signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Non-bone cement fixation of the prosthesis is used; 2. Simultaneous bilateral total knee replacement; 3. Intraoperatively, constrained prostheses, hinged knee joint prostheses, tumor prostheses, special inserts, bone strut cones or metal sleeves are used; 4. Allergic to gentamicin; 5. Patients with autoimmune diseases requiring long-term oral steroids or immunosuppressants; 6. Preoperative abnormal elevation of CRP and ESR (CRP > 10mg/L and ESR > 30mm/H); 7. Pregnant women, postpartum women, and breastfeeding women; 8. Patients unable to tolerate surgery due to heart and lung dysfunction or other underlying conditions; 9. Patients requiring radiation therapy or chemotherapy for malignant diseases; 10. Severe immunodeficiency disorders (such as stage III HIV infection, sickle cell anemia, splenectomy); 11. History of drug abuse in the past; 12. Use of immunosuppressive drugs for bone marrow or other transplants; 13.Currently participating in other clinical trials; 14.The investigator believes that the participant is not suitable for the clinical trial due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the one-year survival rate of the prosthesis after surgery with the endpoint being infection around the prosthesis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Interval time of infection occurrence within 1 year after surgery: the time interval from initial total knee arthroplasty (TKA) to diagnosis of periprosthetic joint infection.;Hospital for Special Surgery knee score;SF-12 Quality of life scale;VAS pain rating scale;incidence of wound dehiscence;incidence of aseptic loosning;Reoperation rate;Cost and cost-effectiveness analysis of bone cement;Microbiological information and drug resistance analysis of infected patients in two groups .; | — |
Countries
China
Contacts
Public ContactCao Li
Department of Orthopaedics, the First Affiliated Hospital of Xinjiang Medical University
Outcome results
None listed