Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty

Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty: a Prospective, Randomized Clinical Survey

The purpose of this study is to compare infection rates when patients, elected for primary or aseptic revision THA / TKA, have a single intravenous antibiotic dose versus one single intravenous antibiotic dose in combination with intra-articular antibiotics. This is a prospective, randomized clinical survey on selected outcome measurements on 1834 subjects who will be recruited in a period of about 2 years.

Study Overview

• Status: Recruiting
• Conditions: Infection
• Intervention / Treatment: Procedure: Arthroplasty

Detailed Description

Group A: patients receiving single dose of IV cefazolin 10-60 minutes before incision.

Group B: patients receiving a single dose of IV cefazolin 10-60 minutes before incision + a single dose of intra-articular vancomycin powder before articulation (hip or knee) closure.

• Study Type: Interventional
• Enrollment (Anticipated): 1832
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karine Tardif; Phone Number: 3465 514-338-2222; Email: karinetardif2@gmail.com
• Study Contact Backup: Name: Benoit Benoit, MD; Phone Number: 2050 514-338-2222; Email: ben1000ben@icloud.com

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4J 1C5
      • Recruiting
      • Hopital Sacre-Coeur de Montreal
      • Contact: Karine Tardif; Phone Number: 3465 514-338-2222; Email: karinetardif2@gmail.com
      • Contact: Benoit Benoit, MD; Phone Number: 2050 514-338-2222; Email: ben1000ben@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Standard criteria for the implantation of primary total hip or knee replacement
• Revision of an aseptic THA or TKA.
• Adults >18 years of age
• Diagnosis of Osteoarthrosis (OA), Osteonecrosis (ON), Arthritis; or aseptic loosening of THA/TKA.
• Subject is willing to consent to participate in the study
• Subject is available for follow-up through at least 2 years
• Subject has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk.
• Subject who are fluent in English and / or French and able to understand their role in the study

Exclusion Criteria:

• Active, local infection or systemic infection.
• Participation in any other pharmaceutical, biologic or medical device clinical investigation
• Subjects with known allergy to vancomycin
• Subjects unable to consent
• Patient with skin pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard; Patients receiving single dose of IV cefazolin (2 grams if < 120kg; 3 grams if >120kg) 10-60 minutes before incision	Procedure: Arthroplasty; All patients include in the study will undergo a lowerlimb arthroplasty, primary or revision; Other Names: Knee arthroplasty; Hip arthroplasty; Knee aseptic revision arthroplasty; Hip arthroplaty revision
Experimental: Vanco; Patients receiving a single dose of IV cefazolin (2 grams if < 120kg; 3 grams if >120kg) 10-60 minutes before incision + a single dose of intra-articular vancomycin powder (1 gram) before articulation (hip or knee) closure	Procedure: Arthroplasty; All patients include in the study will undergo a lowerlimb arthroplasty, primary or revision; Other Names: Knee arthroplasty; Hip arthroplasty; Knee aseptic revision arthroplasty; Hip arthroplaty revision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Infection rate	Infection rate after after lowerlimb arthroplasty depending on the antibiotic molecule that was given	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term infection rate	Infection rate after after lowerlimb arthroplasty depending on the antibiotic molecule that was given	2 years
Risk factor	Infection rate in patients with risk factors depending on the antibiotic molecule that was given	2 years
Primary vs revision	Infection rate in primary versus revisions surgery depending on the antibiotic molecule that was given	2 years
Surgery time	Infection rate according to surgery time depending on the antibiotic molecule that was given	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)	Scale from 0 to 97. 97 indicate worse pain, stiffness, and functional limitations	baseline, 1 year
EQ-5D-5L	The descriptive system section of the EQ-5D questionnaire produces a 5-digit health state profile that represents the level of reported problems on each of the five dimensions of health	baseline, 1 year

Collaborators and Investigators

• Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
• Investigators: Principal Investigator: Benoit Benoit, MD, CIUSSS du Nord de l'Île de Montreal

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: knee arthroplasty; hip arthroplasty; vancomycine; hip revision arthroplasty; knee revision arthroplasty
• Other Study ID Numbers: Single-Dose

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No