Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty

STATUS

Recruiting
End date

Dec 31, 2027
participants needed

1832
sponsor

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

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Updated on 19 February 2024

See if I qualify

total knee replacement

antibiotics

antibiotic therapy

vancomycin

osteonecrosis

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.

Details

Condition	Infection, Infection
Age	18years - 100years
Treatment	Arthroplasty
Clinical Study Identifier	NCT04399642
Sponsor	Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty