Infection Prevention After TKA With or Without Vancomycin
ConditionInfection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorCentre of Postgraduate Medical Education
About this trial
Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in prevention of infection after Total Knee Arthroplasty With or Without Vancomycin.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Gosnartrosis
Disqualifiers
no informed consent to participate in the study age under 40 multilligament injury or single plane knee instability another musculoskeletal disorders in lower limb ASA score > II
Trial design
Design model
Parallel
Treatments tested in this trial
Knee arthroplasty
Procedure/Surgerytotal or unilateral knee arthroplasty
Treatment groups
1,800 Participants
are divided into 2 treatment groupsGroup A: Knee arthroplastySham comparator 1 intervention
Group B: Knee arthroplasty + vancomycinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of surgical site infection
The incidence of deep and superficial SSI after knee arthroplasty
Time frame
up to 24 monthsSecondary outcomes
1
Blood test - CRP
inflammatory reaction - CRP
Time frame
12 weeks,2
Blood test - IL 6
inflammatory reaction - Il-6
Time frame
12 weeks,3
Functional tests
hop-for-distance
Time frame
12 weeks,4
Functional tests
hop-for-distance
Time frame
6 months,Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov