Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04399642
• Other study ID #: Single-Dose
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: July 2021
• Source: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
• Contact: Benoit Benoit, MD
• Phone: 514-338-2222
• Email: ben1000ben[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1832
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection

Intervention

Procedure:
• Arthroplasty
All patients include in the study will undergo a lowerlimb arthroplasty, primary or revision

Locations

Country	Name	City	State
Canada	Hopital Sacré-Coeur de Montreal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Acute Infection rate	Infection rate after after lowerlimb arthroplasty depending on the antibiotic molecule that was given	3 months
Secondary	Long-term infection rate	Infection rate after after lowerlimb arthroplasty depending on the antibiotic molecule that was given	2 years
Secondary	Risk factor	Infection rate in patients with risk factors depending on the antibiotic molecule that was given	2 years
Secondary	Primary vs revision	Infection rate in primary versus revisions surgery depending on the antibiotic molecule that was given	2 years
Secondary	Surgery time	Infection rate according to surgery time depending on the antibiotic molecule that was given	2 years