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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05461651
Other study ID # TKA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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