Local Antibiotic Injection Catheter Acute Periprosthetic Infections Knee DAIR Randomized Controlled TrialYESNCT06468163
Efficacy of Local Antibiotic Injection Via a Catheter for Treating Acute Periprosthetic Infections After Knee DAIR Surgery
A study testing Drug infusion into joint through catheter. in people with Local Antibiotic Injection Catheter Acute Periprosthetic Infections Knee DAIR Randomized Controlled Trial, run by First Affiliated Hospital of Xinjiang Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Local Antibiotic Injection Catheter Acute Periprosthetic Infections Knee DAIR Randomized Controlled Trial
- What is being tested?
- Drug infusion into joint through catheter.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- Drug infusion into joint through catheter.
- Keywords
- Local Antibiotic Injection, Catheter, Acute Periprosthetic Infections, DAIR Surgery, Prospective, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug infusion into joint through catheter.Device
With or without using catheter after DAIR operation for drug infusion.
| Study group | Role | What they receive |
|---|---|---|
| Catheter group | Experimental | Using catheter after knee DAIR surgery. Receives: Device: Drug infusion into joint through catheter. |
| None-catheter group | Active comparator | Without using catheter after knee DAIR surgery. Receives: Device: Drug infusion into joint through catheter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection control rate
Infection control rate
Measured: Two year after surgery
Time between infection recurrence
Time between infection recurrence
Measured: Two year after surgery
Re-operation rate
Re-operation rate
Measured: Two year after surgery
Secondary outcomes (13)
X-ray
X-ray
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One day before surgery and two years after surgery
White blood cell count
White blood cell count from blood
Measured: 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)
Measured: 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).
Measured: One day before surgery and one day after surgery
Synovial fluid white blood count
Synovial fluid white blood count
Measured: 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%.
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: One day before surgery and one day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Antibiotic Injection Catheter Acute Periprosthetic Infections Knee DAIR Randomized Controlled TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long Hua, First Affiliated Hospital of Xinjiang Medical University
- Investigators
- Li Cao, M.D., Study chair, The first affliated hospital, Xinjiang medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468163
- Sponsor's protocol ID
- HL240528-12
- Acronym
- YES
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Rawdata can be asked after paper published.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06468163
- Acronym / sponsor ID
- YES / HL240528-12
- Keywords
- Local Antibiotic Injection, Catheter, Acute Periprosthetic Infections, DAIR Surgery, Prospective, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Xinjiang Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter group | Experimental | Device: Drug infusion into joint through catheter.Using catheter after knee DAIR surgery. |
| None-catheter group | Active comparator | Device: Drug infusion into joint through catheter.Without using catheter after knee DAIR surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug infusion into joint through catheter.With or without using catheter after DAIR operation for drug infusion. | Device | Catheter group, None-catheter group |
Primary outcome
Infection control rate
Time frame: Two year after surgery
Infection control rate
Time between infection recurrence
Time frame: Two year after surgery
Time between infection recurrence
Re-operation rate
Time frame: Two year after surgery
Re-operation rate
13 secondary outcomes
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
Blood Urea Nitrogen （BUN）
Time frame: One day before surgery and one day after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Yes. Rawdata can be asked after paper published.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Cao, M.D. study chair
The first affliated hospital, Xinjiang medical university
Questions about this trial
What is this clinical trial studying?
A study testing Drug infusion into joint through catheter. in people with Local Antibiotic Injection Catheter Acute Periprosthetic Infections Knee DAIR Randomized Controlled Trial, run by First Affiliated Hospital of Xinjiang Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Long Hua, M.D. (+8615099182364, hualong_xmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection control rate (time frame: Two year after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.