NCT05461651
Recruiting
Not Applicable
Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in Prevention of Infection After Total Knee Arthroplasty With or Without Vancomycin.
Centre of Postgraduate Medical Education1 site in 1 country1,800 target enrollmentSeptember 1, 2021
ConditionsInfection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infection
- Sponsor
- Centre of Postgraduate Medical Education
- Enrollment
- 1800
- Locations
- 1
- Primary Endpoint
- Incidence of surgical site infection
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in prevention of infection after Total Knee Arthroplasty With or Without Vancomycin.
Detailed Description
Infection after surgery is one of the most common complication after total knee replacement. Our prospective randomized study is intended to show if addition of vancomycin to the joint before the wound closure will decrease infection after operation.
Investigators
Rafał Kamiński
Professor
Centre of Postgraduate Medical Education
Eligibility Criteria
Inclusion Criteria
- •Gosnartrosis
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Incidence of surgical site infection
Time Frame: up to 24 months
The incidence of deep and superficial SSI after knee arthroplasty
Secondary Outcomes
- Blood test - CRP(12 weeks,)
- Blood test - IL 6(12 weeks,)
- Functional tests(24 months)
- Knee injury and Osteoarthritis Outcome Score(24 months)
- 36-Item Short Form Survey(24 months)
- Visual analog Scale(24 months)
- Tegner Lysholm Knee Scoring Scale(24 months)
Study Sites (1)
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