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Comparison of inflammatory response in TKA patients using antibiotic bone cement versus non-antibiotic bone cement

Comparison of inflammatory response in TKA patients using antibiotic bone cement versus non-antibiotic bone cement

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250219004
Enrollment
64
Registered
2025-02-19
Start date
2018-10-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-staged knee osteoarthritis Total Knee Arthroplasty (TKA) Antibiotic Bone Cement (ABC) Inflammatory Response Interleukin-6 (IL-6) C-Reactive Protein (CRP)

Interventions

use antibiotic-loaded bone cement in TKA,use non-antibiotic bone cement in TKA
Active Comparator Drug,Active Comparator Drug
antibiotic-loaded bone cement group,non-antibiotic bone cement group

Sponsors

Navamindradhiraj University Research Fund
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
55 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 55-75 years diagnosed with Kellgren and Lawrence grade 3-4 KL3-4 knee osteoarthritis. 2. Patients who had failed conservative treatment. 3. Patients undergoing primary TKA for the affected knee. 4. Patients undergoing cemented TKA technique.

Exclusion criteria

Exclusion criteria: 1. Patients with knee osteoarthritis due to inflammatory joint diseases such as gout, pseudo-gout, rheumatoid arthritis, or spondyloarthropathy. 2. Presence of infection or suspected infection in the affected knee or a history of septic arthritis. 3. History of any previous knee surgery on the affected knee or procedures that could impact knee function. 4. Suspected immune deficiency, chronic liver disease, or use of immunosuppressive drugs. 5. History of gentamicin allergy. 6. Patients unable to ambulate postoperatively.

Design outcomes

Primary

MeasureTime frame
Inflammatory marker 3 days, 14 days postoperative Serum IL-6, Serum CRP, Serum ESR, Joint IL-6, Joint CRP

Secondary

MeasureTime frame
Knee clinical outcome 14 days postoperative KOOS,Complication 14 days postoperative SSI, PJI

Countries

Thailand

Contacts

Public ContactPruk Chaiyakit

Faculty of Medicine, Vajira Hospital, Navamindradhiraj University

pruk@nmu.ac.th022443376

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026