Intrawound Administration of Vancomycin in TKA

Not Applicable

Completed

• Conditions: Knee Osteoarthritis

• Registration Number: NCT05338021
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-17
• Study First Posted: 2022-04-20
• Study Start: 2022-05-25
• Primary Completion: 2022-09-07
• Study Completion: 2022-09-07
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intra-articular vancomycin concentration	2 hours, 8 hours and 24 hours postoperatively
Serum vancomycin concentration	2 hours, 8 hours and 24 hours postoperatively
Renal function	Postoperative Day 1 and Day 3	blood urea nitrogen (BUN), creatinine (Cr), GFR
Blood loss	Postoperative Day 3

Trial Locations

Locations (1)

The affiliated hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China