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Clinical Trials/NCT06468163
NCT06468163
Not yet recruiting
Not Applicable

Efficacy of Local Antibiotic Injection Via a Catheter for Treating Acute Periprosthetic Infections After Knee DAIR Surgery: A Prospective, Randomized Controlled Trial Study

First Affiliated Hospital of Xinjiang Medical University0 sites200 target enrollmentAugust 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Local Antibiotic Injection Catheter Acute Periprosthetic Infections Knee DAIR Randomized Controlled Trial
Sponsor
First Affiliated Hospital of Xinjiang Medical University
Enrollment
200
Primary Endpoint
Infection control rate
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

Prosthetic Joint Infection (PJI) is a severe complication following joint replacement surgery, imposing significant economic and health burdens on patients. For acute PJI, the DAIR (Debridement, Antibiotics, and Implant Retention) procedure is a necessary and effective treatment method, as it effectively clears the infection while preserving the prosthesis, thereby avoiding more complex surgical interventions. However, the practice of using drainage tubes postoperatively is controversial. Some studies suggest that drainage tubes may increase the risk of infection, while other literature indicates no statistically significant difference in infection risk associated with their use.In this context, Professor Li Cao's team at Xinjiang Medical University has improved the traditional DAIR procedure by incorporating long-term local antibiotic injections post-surgery, achieving positive results. Despite this, the specific method of antibiotic injection, particularly whether to use a drug infusion tube, remains under debate. The use of an infusion tube can reduce patient discomfort, shorten the local disinfection process, and theoretically decrease the time the incision is exposed to the external environment, potentially lowering the infection risk. However, the validity of these theoretical assumptions needs further confirmation through high-level scientific research. This study aims to evaluate whether there are differences in joint function recovery, changes in blood infection markers, and the incidence of postoperative complications between using and not using an infusion tube for local antibiotic injection after knee DAIR surgery. To assess the value of the infusion tube in local antibiotic injection post-knee DAIR surgery, a randomized controlled trial (RCT) will be conducted. Eligible patients will be randomly assigned to the infusion tube group (experimental group) or the non-infusion tube group (control group). The study will prospectively collect basic information, joint function scores, blood infection markers, and postoperative complication data from both groups, including patient age, gender, educational background, and postoperative blood test results. Ultimately, the RCT aims to demonstrate the therapeutic efficacy of the infusion tube method.

Registry
clinicaltrials.gov
Start Date
August 1, 2024
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
First Affiliated Hospital of Xinjiang Medical University
Responsible Party
Principal Investigator
Principal Investigator

Long Hua

Doctor

First Affiliated Hospital of Xinjiang Medical University

Eligibility Criteria

Inclusion Criteria

  • Age ≥18 years old, gender is not limited;
  • Meet the diagnostic criteria for DAIR surgery of artificial knee joint;
  • Receiving knee DAIR surgery;
  • Voluntary and signed informed consent.

Exclusion Criteria

  • Patients with chronic PJI infection undergoing total knee revision;
  • Patients with severe knee joint infection who cannot undergo artificial joint replacement;
  • Progressive renal insufficiency (stage 4 and above) or glomerular filtration rate less than 30ml/min;
  • periprosthesis infection after multiple joint replacement;
  • Active infection at the site of intravenous or joint injection;
  • long-term use of anticoagulants or antiplatelet drugs due to other diseases;
  • Have sepsis or positive blood culture within the last 30 days;
  • Radiotherapy and chemotherapy are required due to neoplastic diseases;
  • Receiving systemic glucocorticoid therapy (prednisone \> 10mg/ day or equivalent hormone medication);
  • severe immunodeficiency diseases (such as stage 3 HIV, sickle cell anemia, splenectomy, etc.);

Outcomes

Primary Outcomes

Infection control rate

Time Frame: Two year after surgery

Infection control rate

Re-operation rate

Time Frame: Two year after surgery

Re-operation rate

Time between infection recurrence

Time Frame: Two year after surgery

Time between infection recurrence

Secondary Outcomes

  • C-reactive protein (CRP)(One day before surgery and one day after surgery)
  • Redness, Edema, Ecchymosis, Discharge, and Approximation score (REEDA score)(One day before surgery, three month after surgery)
  • White blood cell count(One day before surgery and one day after surgery)
  • Erythrocyte sedimentation rate (ESR)(One day before surgery and one day after surgery)
  • Serum Creatinine(One day before surgery and one day after surgery)
  • American Knee Society Score (AKS score)(One day before surgery and two years after surgery)
  • Visual Analog Scale score(One day before surgery and two years after surgery)
  • X-ray(One day before surgery and two years after surgery)
  • Synovial fluid white blood count(One day before surgery and one day after surgery)
  • Polymorphonuclear neutrophil percentage in synovial fluid (SF-PMN)(One day before surgery and one day after surgery)
  • Alanine Aminotransferase (ALT)(One day before surgery and one day after surgery)
  • Aspartate Aminotransferase (AST)(One day before surgery and one day after surgery)
  • Blood Urea Nitrogen (BUN)(One day before surgery and one day after surgery)

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