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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Active Comparator | Patients receiving single dose of IV cefazolin (2 grams if < 120kg; 3 grams if >120kg) 10-60 minutes before incision |
|
| Vanco | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroplasty | Procedure | All patients include in the study will undergo a lowerlimb arthroplasty, primary or revision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Infection rate | Infection rate after after lowerlimb arthroplasty depending on the antibiotic molecule that was given | 3 months |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benoit Benoit, MD | CIUSSS du Nord de l'ÃŽle de Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Sacré-Coeur de Montreal | Montreal | Quebec | H4J 1C5 | Canada |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019645 | Arthroplasty, Replacement, Knee |
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019643 | Arthroplasty, Replacement |
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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
| 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 |
| baseline, 1 year |
| D019919 | Prosthesis Implantation |