Intrawound Administration of Vancomycin in TKA

NCT05338021 | Completed

• 1 other identifier: AHQingdao VancoTKA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• 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

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

  Postoperative Day 1 and Day 3

• Blood loss

  Postoperative Day 3

Study Arms (2)

Intrawound Administration of Vancomycin

EXPERIMENTAL

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. Then 20ml of normal saline was injected directly into the joint.

Procedure: Intrawound administration of vancomycin after closure of the arthrotomy

Intrawound Administration of Vancomycin combined with epsilon-aminocaproic acid (EACA)

EXPERIMENTAL

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. Then 4g (20ml) of epsilon-aminocaproic acid (EACA) was injected directly into the joint.

Procedure: Intrawound administration of vancomycin after closure of the arthrotomy

Interventions

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.

Intrawound Administration of Vancomycin; Intrawound Administration of Vancomycin combined with epsilon-aminocaproic acid (EACA)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The affiliated hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Related Publications (1)

• Li X, Lai J, Yang X, Xu H, Xiang S. Intra-articular injection of vancomycin after arthrotomy closure following gentamicin-impregnated bone cementation in primary total knee arthroplasty provides a high intra-articular concentration while avoiding systemic toxicity: a prospective study. J Orthop Surg Res. 2024 Dec 19;19(1):856. doi: 10.1186/s13018-024-05357-9.

  PMID: 39702402 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Shuai Xiang, M.D.

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 20, 2022
• Study Start: May 25, 2022
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completing this trial.

Locations

CN (1)