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Infection Prevention After TKA With or Without Vancomycin (TKA_Vanco)

Primary Purpose

Infection

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Knee arthroplasty
Sponsored by
Centre of Postgraduate Medical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection focused on measuring TKA, Vancomycin

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Knee arthroplasty

Knee arthroplasty + vancomycin

Arm Description

Knee arthroplasty without addition of antibiotic wash oraz antibitiotic powder to the surgery site

Knee arthroplasty with addition of vancomysin powder to the surgery site

Outcomes

Primary Outcome Measures

Incidence of surgical site infection
The incidence of deep and superficial SSI after knee arthroplasty

Secondary Outcome Measures

Blood test - CRP
inflammatory reaction - CRP
Blood test - IL 6
inflammatory reaction - Il-6
Functional tests
hop-for-distance
Functional tests
hop-for-distance
Functional tests
hop-for-distance
Functional tests
hop-for-distance
Knee injury and Osteoarthritis Outcome Score
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).
Knee injury and Osteoarthritis Outcome Score
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).
Knee injury and Osteoarthritis Outcome Score
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).
Knee injury and Osteoarthritis Outcome Score
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
Quality of life, pain SF-36
36-Item Short Form Survey
Quality of life, pain SF-36
36-Item Short Form Survey
Quality of life, pain SF-36
36-Item Short Form Survey
Quality of life, pain SF-36
Visual analog Scale
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).
Visual analog Scale
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).
Visual analog Scale
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).
Visual analog Scale
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
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).
Tegner Lysholm Knee Scoring Scale
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).
Tegner Lysholm Knee Scoring Scale
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).
Tegner Lysholm Knee Scoring Scale
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).

Full Information

First Posted
February 3, 2022
Last Updated
July 13, 2022
Sponsor
Centre of Postgraduate Medical Education
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1. Study Identification

Unique Protocol Identification Number
NCT05461651
Brief Title
Infection Prevention After TKA With or Without Vancomycin
Acronym
TKA_Vanco
Official Title
Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in Prevention of Infection After Total Knee Arthroplasty With or Without Vancomycin.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 1, 2028 (Anticipated)
Study Completion Date
January 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre of Postgraduate Medical Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
TKA, Vancomycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Knee arthroplasty
Arm Type
Sham Comparator
Arm Description
Knee arthroplasty without addition of antibiotic wash oraz antibitiotic powder to the surgery site
Arm Title
Knee arthroplasty + vancomycin
Arm Type
Active Comparator
Arm Description
Knee arthroplasty with addition of vancomysin powder to the surgery site
Intervention Type
Procedure
Intervention Name(s)
Knee arthroplasty
Intervention Description
total or unilateral knee arthroplasty
Primary Outcome Measure Information:
Title
Incidence of surgical site infection
Description
The incidence of deep and superficial SSI after knee arthroplasty
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Blood test - CRP
Description
inflammatory reaction - CRP
Time Frame
12 weeks,
Title
Blood test - IL 6
Description
inflammatory reaction - Il-6
Time Frame
12 weeks,
Title
Functional tests
Description
hop-for-distance
Time Frame
12 weeks,
Title
Functional tests
Description
hop-for-distance
Time Frame
6 months,
Title
Functional tests
Description
hop-for-distance
Time Frame
12 months
Title
Functional tests
Description
hop-for-distance
Time Frame
24 months
Title
Knee injury and Osteoarthritis Outcome Score
Description
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).
Time Frame
6 weeks
Title
Knee injury and Osteoarthritis Outcome Score
Description
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).
Time Frame
6 months
Title
Knee injury and Osteoarthritis Outcome Score
Description
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).
Time Frame
12 months
Title
Knee injury and Osteoarthritis Outcome Score
Description
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).
Time Frame
24 months
Title
36-Item Short Form Survey
Description
Quality of life, pain SF-36
Time Frame
6 weeks
Title
36-Item Short Form Survey
Description
Quality of life, pain SF-36
Time Frame
6 months
Title
36-Item Short Form Survey
Description
Quality of life, pain SF-36
Time Frame
12 months
Title
36-Item Short Form Survey
Description
Quality of life, pain SF-36
Time Frame
24 months
Title
Visual analog Scale
Description
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).
Time Frame
6 weeks
Title
Visual analog Scale
Description
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).
Time Frame
6 months
Title
Visual analog Scale
Description
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).
Time Frame
12 months
Title
Visual analog Scale
Description
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).
Time Frame
24 months
Title
Tegner Lysholm Knee Scoring Scale
Description
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).
Time Frame
6 weeks
Title
Tegner Lysholm Knee Scoring Scale
Description
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).
Time Frame
6 months
Title
Tegner Lysholm Knee Scoring Scale
Description
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).
Time Frame
12 months
Title
Tegner Lysholm Knee Scoring Scale
Description
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).
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafal Kaminski, MD PhD
Phone
48 227754031
Ext
469
Email
rkaminski@spskgruca.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafal KAminski
Organizational Affiliation
CMKP
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital
City
Otwock
State/Province
Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafal Kaminski, MD PhD
Phone
+48227794031
Ext
469
Email
rkaminski@spskgruca.pl
First Name & Middle Initial & Last Name & Degree
Stanislaw Pomianowski, MD PhD Prof
Phone
+48227794031
Ext
481
Email
spom@spskgruca.pl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Infection Prevention After TKA With or Without Vancomycin

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