Infection Prevention After TKA With or Without Vancomycin

Not Applicable

Recruiting

• Conditions: Infection
• Interventions: Procedure: Knee arthroplasty

• Registration Number: NCT05461651
• Lead Sponsor: Centre of Postgraduate Medical Education

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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-02-03
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-13
• Last Update Submitted: 2022-07-13
• Study First Posted: 2022-07-18
• Last Update Posted: 2022-07-18
• Primary Completion: 2028-01-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Knee arthroplasty	Knee arthroplasty	Knee arthroplasty without addition of antibiotic wash oraz antibitiotic powder to the surgery site
Knee arthroplasty + vancomycin	Knee arthroplasty	Knee arthroplasty with addition of vancomysin powder to the surgery site

Primary Outcome Measures

Name	Time	Method
Incidence of surgical site infection	up to 24 months	The incidence of deep and superficial SSI after knee arthroplasty

Secondary Outcome Measures

Name	Time	Method
Blood test - CRP	12 weeks,	inflammatory reaction - CRP
Blood test - IL 6	12 weeks,	inflammatory reaction - Il-6
Functional tests	24 months	hop-for-distance
Knee injury and Osteoarthritis Outcome Score	24 months	Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).
36-Item Short Form Survey	24 months	Quality of life, pain SF-36
Visual analog Scale	24 months	Pain Visual Analog Scale; The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)\[8\] orientated from the left (worst) to the right (best).
Tegner Lysholm Knee Scoring Scale	24 months	The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).

Trial Locations

Locations (1)

Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital; 🇵🇱 Otwock, Mazowieckie, Poland