Infection Prevention After TKA With or Without Vancomycin

Infection Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461651
• Other study ID #: TKA
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: January 1, 2029

Study information

• Verified date: July 2022
• Source: Centre of Postgraduate Medical Education
• Contact: Rafal Kaminski, MD PhD
• Phone: 48 227754031
• Email: rkaminski[@]spskgruca.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in prevention of infection after Total Knee Arthroplasty With or Without Vancomycin.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infections

Intervention

Procedure:
• Knee arthroplasty
total or unilateral knee arthroplasty

Locations

Country	Name	City	State
Poland	Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital	Otwock	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of surgical site infection	The incidence of deep and superficial SSI after knee arthroplasty	up to 24 months
Secondary	Blood test - CRP	inflammatory reaction - CRP	12 weeks,
Secondary	Blood test - IL 6	inflammatory reaction - Il-6	12 weeks,
Secondary	Functional tests	hop-for-distance	12 weeks,
Secondary	Functional tests	hop-for-distance	6 months,
Secondary	Functional tests	hop-for-distance	12 months
Secondary	Functional tests	hop-for-distance	24 months
Secondary	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).	6 weeks
Secondary	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).	6 months
Secondary	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).	12 months
Secondary	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).	24 months
Secondary	36-Item Short Form Survey	Quality of life, pain SF-36	6 weeks
Secondary	36-Item Short Form Survey	Quality of life, pain SF-36	6 months
Secondary	36-Item Short Form Survey	Quality of life, pain SF-36	12 months
Secondary	36-Item Short Form Survey	Quality of life, pain SF-36	24 months
Secondary	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).	6 weeks
Secondary	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).	6 months
Secondary	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).	12 months
Secondary	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).	24 months
Secondary	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).	6 weeks
Secondary	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).	6 months
Secondary	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).	12 months
Secondary	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).	24 months