Efficacy of Local Antibiotic Injection Via a Catheter for Treating Acute Periprosthetic Infections After Knee DAIR Surgery

Official title

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

Overview

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.

Interventions

• Device Drug infusion into joint through catheter.
  With or without using catheter after DAIR operation for drug infusion.

Primary outcome measures

• Infection control rate [Time frame: Two year after surgery]
• Time between infection recurrence [Time frame: Two year after surgery]
• Re-operation rate [Time frame: Two year after surgery]

Secondary outcome measures (12)

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

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.);
• Have a history of drug abuse;
• Treatment of bone marrow or other transplants with immunosuppressive drugs;
• Pregnant, parturient and lactating women;
• Participating in other clinical trials;
• Researchers believe that other reasons are not appropriate for clinical trial participants.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06468163 · HL240528-12

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗