Clinical trial NCT06468163: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Local Antibiotic Injection Catheter Acute Periprosthetic Infections Knee DAIR Randomized Controlled Trial
Keywords: Local Antibiotic Injection
Catheter
Acute Periprosthetic Infections
DAIR Surgery
Prospective
Randomized Controlled Trial
Lead sponsor: First Affiliated Hospital of Xinjiang Medical University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with chronic PJI infection undergoing total knee revision;
2. Patients with severe knee joint infection who cannot undergo artificial joint replacement;
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.

Primary outcomes:
measure: Infection control rate
timeFrame: Two year after surgery
measure: Time between infection recurrence
timeFrame: Two year after surgery
measure: Re-operation rate
timeFrame: Two year after surgery
Secondary outcomes:
measure: X-ray
timeFrame: One day before surgery and two years after surgery
measure: American Knee Society Score （AKS score）
timeFrame: One day before surgery and two years after surgery
measure: Redness, Edema, Ecchymosis, Discharge, and Approximation score (REEDA score)
timeFrame: One day before surgery, three month after surgery
measure: Visual Analog Scale score
timeFrame: One day before surgery and two years after surgery
measure: White blood cell count
timeFrame: One day before surgery and one day after surgery
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: One day before surgery and one day after surgery
measure: C-reactive protein (CRP)
timeFrame: One day before surgery and one day after surgery
measure: Synovial fluid white blood count
timeFrame: One day before surgery and one day after surgery
measure: Polymorphonuclear neutrophil percentage in synovial fluid (SF-PMN)
timeFrame: One day before surgery and one day after surgery
measure: Alanine Aminotransferase (ALT)
timeFrame: One day before surgery and one day after surgery
measure: Aspartate Aminotransferase (AST)
timeFrame: One day before surgery and one day after surgery
measure: Serum Creatinine
timeFrame: One day before surgery and one day after surgery
measure: Blood Urea Nitrogen （BUN）
timeFrame: One day before surgery and one day after surgery
Other outcomes:
Locations:
Study officials:
affiliation: The first affliated hospital, Xinjiang medical university
name: Li Cao, M.D.
role: STUDY_CHAIR
References: