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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Local Antibiotic Injection Catheter Acute Periprosthetic Infections Knee DAIR Randomized Controlled Trial
• Intervention / Treatment: Device: Drug infusion into joint through catheter.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Long Hua, M.D.; Phone Number: +8615099182364; Email: hualong_xmu@163.com
• Study Contact Backup: Name: Li Cao, M.D.; Phone Number: +8613909915960; Email: xjbone@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Catheter group; Using catheter after knee DAIR surgery.	Device: Drug infusion into joint through catheter.; With or without using catheter after DAIR operation for drug infusion.
Active Comparator: None-catheter group; Without using catheter after knee DAIR surgery.	Device: Drug infusion into joint through catheter.; With or without using catheter after DAIR operation for drug infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection control rate	Infection control rate	Two year after surgery
Time between infection recurrence	Time between infection recurrence	Two year after surgery
Re-operation rate	Re-operation rate	Two year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
X-ray	X-ray	One day before surgery and two years after surgery
American Knee Society Score （AKS score）	American Knee Society Score is used to evaluate the outcomes of knee replacement surgery. This scoring system consists of two main components: the knee score and the function score. Knee Score: This primarily assesses the condition of the knee joint itself, including pain, stability, and range of motion. The higher of the score, the better of the functional result.	One day before surgery and two years after surgery
Redness, Edema, Ecchymosis, Discharge, and Approximation score (REEDA score)	The REEDA score is a clinical tool used to assess the healing of perineal wounds and other skin wounds, particularly after childbirth. REEDA stands for Redness, Edema, Ecchymosis, Discharge, and Approximation. Each of these five parameters is scored on a scale from 0 to 3, with higher scores indicating more severe symptoms. The total REEDA score can range from 0 to 15.	One day before surgery, three month after surgery
Visual Analog Scale score	The VAS score, or Visual Analog Scale, is a tool commonly used to measure a person's level of pain. The VAS is a simple, subjective measure that consists of a straight line, typically 10 centimeters long, anchored by two endpoints. One end of the line represents "no pain" and the other end represents "worst pain imaginable." For example, if the VAS line is 10 cm long and the patient's mark is at 7 cm from the "no pain" end, their pain score would be 7 out of 10.	One day before surgery and two years after surgery
White blood cell count	White blood cell count from blood	One day before surgery and one day after surgery
Erythrocyte sedimentation rate (ESR)	It measures the rate at which red blood cells settle to the bottom of a test tube within one hour. Normal ranges: Male: 0 to 15 millimeters per hour (mm/hr) Female: 0 to 20 millimeters per hour (mm/hr)	One day before surgery and one day after surgery
C-reactive protein (CRP)	C-reactive protein (CRP) is a protein produced by the liver that significantly increases in response to inflammation or infection. Normal range for CRP is less than 10 milligrams per liter (mg/L).	One day before surgery and one day after surgery
Synovial fluid white blood count	Synovial fluid white blood count	One day before surgery and one day after surgery
Polymorphonuclear neutrophil percentage in synovial fluid (SF-PMN)	Polymorphonuclear neutrophil percentage in synovial fluid refers to the proportion or percentage of polymorphonuclear neutrophils (PMN) present in the synovial fluid. This measurement is important in the assessment of joint health and inflammation, particularly in conditions such as arthritis and infections affecting the joints. Normal range: Less than 80%.	One day before surgery and one day after surgery
Alanine Aminotransferase (ALT)	An enzyme found in the liver that helps convert proteins into energy. Elevated levels indicate liver damage. Normal range: 10 to 40 units per liter (U/L)	One day before surgery and one day after surgery
Aspartate Aminotransferase (AST)	An enzyme found in the liver and other tissues. High levels can indicate liver damage but are less specific than ALT. Normal range: 10 to 40 units per liter (U/L)	One day before surgery and one day after surgery
Serum Creatinine	Measures the level of creatinine in the blood. Elevated levels can indicate impaired kidney function. Normal range: 62 to 115 micromoles per liter (µmol/L).	One day before surgery and one day after surgery
Blood Urea Nitrogen （BUN）	Measures the amount of nitrogen in the blood that comes from urea. Elevated BUN levels can indicate impaired kidney function. Normal range: 2.5 to 7.1 millimoles per liter (mmol/L).	One day before surgery and one day after surgery

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Xinjiang Medical University
• Investigators: Study Chair: Li Cao, M.D., The first affliated hospital, Xinjiang medical university

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 15, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 15, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Catheter; Prospective; Local Antibiotic Injection; Acute Periprosthetic Infections; DAIR Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: HL240528-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Rawdata can be asked after paper published.
• IPD Sharing Time Frame: Rawdata can be asked after paper published.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No