Infection
Conditions
Keywords
vancomycine, hip arthroplasty, knee arthroplasty, hip revision arthroplasty, knee revision arthroplasty
Brief 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.
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.
Interventions
PROCEDUREArthroplasty
All patients include in the study will undergo a lowerlimb arthroplasty, primary or revision
Sponsors
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Infection rate | 3 months | Infection rate after after lowerlimb arthroplasty depending on the antibiotic molecule that was given |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term infection rate | 2 years | Infection rate after after lowerlimb arthroplasty depending on the antibiotic molecule that was given |
| Risk factor | 2 years | Infection rate in patients with risk factors depending on the antibiotic molecule that was given |
| Primary vs revision | 2 years | Infection rate in primary versus revisions surgery depending on the antibiotic molecule that was given |
| Surgery time | 2 years | Infection rate according to surgery time depending on the antibiotic molecule that was given |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | baseline, 1 year | Scale from 0 to 97. 97 indicate worse pain, stiffness, and functional limitations |
| EQ-5D-5L | baseline, 1 year | 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 |
Countries
Canada
Outcome results
None listed