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OpenTrials
Completed

NCT Number: NCT05338021

Intrawound Administration of Vancomycin in TKA

The purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total knee arthroplasty.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The affiliated hospital of Qingdao University

Qingdao, Shandong, 266000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 50 and 80
  • Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis

Exclusion criteria

  • Diminished mental capacity
  • Vancomycin allergy
  • Chronic kidney disease stage III and stage IV

Treatment and study plan

Intrawound administration of vancomycin after closure of the arthrotomy

Procedure

After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle.

Primary outcomes

  1. Intra-articular vancomycin concentration

    Time frame: 2 hours, 8 hours and 24 hours postoperatively

  2. Serum vancomycin concentration

    Time frame: 2 hours, 8 hours and 24 hours postoperatively

  3. Renal function

    Time frame: Postoperative Day 1 and Day 3

    blood urea nitrogen (BUN), creatinine (Cr), GFR

  4. Blood loss

    Time frame: Postoperative Day 3

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

Serum and Wound Vancomycin Levels Following Intrawound Administration in Primary Total Knee Arthroplasty

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2022
Registry last updated
Jan 19, 2023

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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