Intrawound Administration of Vancomycin in TKA

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05338021
• Other study ID #: AHQingdao VancoTKA
• Status: Completed
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: September 7, 2022

Study information

• Verified date: January 2023
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 7, 2022
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age between 50 and 80

2. Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis

Exclusion Criteria:

1. Diminished mental capacity

2. Vancomycin allergy

3. Chronic kidney disease stage III and stage IV

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Intrawound administration of vancomycin after closure of the arthrotomy
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.

Locations

Country	Name	City	State
China	The affiliated hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-articular vancomycin concentration		2 hours, 8 hours and 24 hours postoperatively
Primary	Serum vancomycin concentration		2 hours, 8 hours and 24 hours postoperatively
Primary	Renal function	blood urea nitrogen (BUN), creatinine (Cr), GFR	Postoperative Day 1 and Day 3
Primary	Blood loss		Postoperative Day 3