Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1832 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-05

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Because of the nature of the intervention, it is impossible for the surgeon to be blinded. However, postoperative infection will be diagnosed by an independent co-worker, not involved in the surgery. Patients will be blind as they will not be aware if they had intra-articular vancomycin powder or not

Study Groups

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Standard

Patients receiving single dose of IV cefazolin (2 grams if \< 120kg; 3 grams if \>120kg) 10-60 minutes before incision

Group Type ACTIVE_COMPARATOR

Arthroplasty

Intervention Type PROCEDURE

All patients include in the study will undergo a lowerlimb arthroplasty, primary or revision

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

Group Type EXPERIMENTAL

Arthroplasty

Intervention Type PROCEDURE

All patients include in the study will undergo a lowerlimb arthroplasty, primary or revision

Interventions

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Arthroplasty

All patients include in the study will undergo a lowerlimb arthroplasty, primary or revision

Intervention Type PROCEDURE

Other Intervention Names

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Knee arthroplasty Hip arthroplasty Knee aseptic revision arthroplasty Hip arthroplaty revision

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No