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Intra-articular injection of antibiotics after one-stage revision for the treatment of chronic knee periprosthetic joint infection: a multicenter, prospective, randomized controlled trial

Intra-articular injection of antibiotics after one-stage revision for the treatment of chronic knee periprosthetic joint infection: a multicenter, prospective, randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022102
Enrollment
Unknown
Registered
2019-03-25
Start date
2023-11-20
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

periprosthetic knee infection

Interventions

Topical administration group:intra-articular injection of antibiotics
Intravenous administration group :Intravenous antibiotics

Sponsors

The First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.The age is =18 years,can be male or female. 2.Chronic Periprosthetic Infections After Joint Replacement Diagnosed in Accordance with the Bone and Muscle System Infection Society 2018 3.Patients undergoing one-stage total knee revision surgery. 4.Patients voluntarily sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1. Allergic to vancomycin or meropenem; 2. The results of pathogen culture were fungi, vancomycin-resistant pathogens, meropenem resistant pathogens. 3. Progressive renal insufficiency (stage 4 and above) or glomerular filtration rate less than 30ml/min; 4. Periprosthesis infection after multiple joint replacement; 5. Active infection at the site of intravenous or joint injection; 6. Long-term use of anticoagulants or antiplatelet drugs due to other diseases; 7. Have sepsis or positive blood culture within the last 30 days; 8. Radiotherapy and chemotherapy are required due to neoplastic diseases; 9. Receiving systemic glucocorticoid therapy (prednisone > 10mg/ day or equivalent hormone medication); 10. Severe immunodeficiency diseases (such as stage 3 HIV, sickle cell anemia, splenectomy, etc.); 11. Have a history of drug abuse; 12. Treatment of bone marrow or other transplants with immunosuppressive drugs; 13. Pregnant, parturient and lactating women; 14. Participating in other clinical trials; 15. Researchers believe that other reasons are not appropriate for clinical trial participants.

Design outcomes

Primary

MeasureTime frame
Erythrocyte sedimentation rate;C-reactive protein;infection recurrence;

Secondary

MeasureTime frame
Hospital for Special Surgery knee score;SF-12 Quality of life scale;VAS pain rating scale;Blood RT;hepatic and renal function;Antibiotic dosage;Antibiotic concentration in joint fluid;Concentration of antibiotics in the blood;

Countries

China

Contacts

Public ContactCao Li

Department of Orthopaedics, the First Affiliated Hospital of Xinjiang Medical University

jbcjoint@126.com+86 139 0991 5960

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026