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NCT Number: NCT05461651

Infection Prevention After TKA With or Without Vancomycin

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

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Key information

Conditions

Infection Infections

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Otwock, Masovian Voivodeship, 05-400, Poland

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Knee arthroplasty

Procedure

total or unilateral knee arthroplasty

Primary outcomes

  1. Incidence of surgical site infection

    Time frame: up to 24 months

    The incidence of deep and superficial SSI after knee arthroplasty

Secondary outcomes

  1. Blood test - CRP

    Time frame: 12 weeks,

    inflammatory reaction - CRP

  2. Blood test - IL 6

    Time frame: 12 weeks,

    inflammatory reaction - Il-6

  3. Functional tests

    Time frame: 12 weeks,

    hop-for-distance

  4. Functional tests

    Time frame: 6 months,

    hop-for-distance

  5. Functional tests

    Time frame: 12 months

    hop-for-distance

  6. Functional tests

    Time frame: 24 months

    hop-for-distance

  7. Knee injury and Osteoarthritis Outcome Score

    Time frame: 6 weeks

    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).

  8. Knee injury and Osteoarthritis Outcome Score

    Time frame: 6 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).

  9. Knee injury and Osteoarthritis Outcome Score

    Time frame: 12 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).

  10. Knee injury and Osteoarthritis Outcome Score

    Time frame: 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).

  11. 36-Item Short Form Survey

    Time frame: 6 weeks

    Quality of life, pain SF-36

  12. 36-Item Short Form Survey

    Time frame: 6 months

    Quality of life, pain SF-36

  13. 36-Item Short Form Survey

    Time frame: 12 months

    Quality of life, pain SF-36

  14. 36-Item Short Form Survey

    Time frame: 24 months

    Quality of life, pain SF-36

  15. Visual analog Scale

    Time frame: 6 weeks

    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).

  16. Visual analog Scale

    Time frame: 6 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).

  17. Visual analog Scale

    Time frame: 12 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).

  18. Visual analog Scale

    Time frame: 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).

  19. Tegner Lysholm Knee Scoring Scale

    Time frame: 6 weeks

    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).

  20. Tegner Lysholm Knee Scoring Scale

    Time frame: 6 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).

  21. Tegner Lysholm Knee Scoring Scale

    Time frame: 12 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).

  22. Tegner Lysholm Knee Scoring Scale

    Time frame: 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).

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Centre of Postgraduate Medical Education

Other

Registry information

Official study title

Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in Prevention of Infection After Total Knee Arthroplasty With or Without Vancomycin.

Acronym: TKA_Vanco

Important dates

Study start
2021
Primary completion
2028
Study completion
2029
First posted
Jul 18, 2022
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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