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| Name | Class |
|---|---|
| Sint Maartenskliniek | OTHER |
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The goal of this randomized control trial is to investigate the superiority of 5 days (extended) versus a single dose of cefazolin prophylaxis in revision arthroplasty of the hip and knee. The main question[s] it aims to answer are:
[question 2] Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items]. If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects].
Periprosthetic joint infection (PJI) is an important complication of total joint arthroplasty of the hip and knee and occurs in 1-2% after primary arthroplasty and in 10-15% after revision arthroplasty. To prevent a PJI, peri-operative antibiotic prophylaxis is given. There's inadequate evidence for a recommendation about the optimal duration of prophylaxis, especially in revision arthroplasty. The aim of this multicenter open-label, randomized controlled trial is to investigate the superiority of 5 days (extended) versus a single dose of cefazolin prophylaxis in revision arthroplasty of the hip and knee. Patients will be recruited at the orthopedic departments of two Dutch hospitals, University Medical Center Radboudumc Nijmegen (Radboudumc) and Sint Maartenskliniek in Nijmegen (SMK). Patients will be included if they will undergo revision arthroplasty of the hip or knee, with exclusion of patients with a proven PJI at baseline. A total of 780 subjects will be randomized between 2 prophylactic strategies: A) Cefazolin at a single dose of 2 grams intravenously 15-60 minutes before incision; B) Cefazolin at a dose of 2 grams intravenously 15-60 minutes before incision, followed by cefazolin 1 gram intravenously t.i.d. until five days post-surgery. The primary endpoint is the difference in proportion of infectious-free implant survival between both groups within 1 year of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single dose cefazolin prophylaxis | No Intervention | prophylaxis according current guidelines single dose 2000mg cefazolin 15-30 minutes before incision | |
| extended cefazolin prophylaxis | Experimental | 5 days of cefazolin prophylaxis start dose 2000mg followed by 14 doses of 1000mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefazolin | Drug | cefazolin extended prophylaxis 5 days (15 doses) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of revision arthroplasty |
| 1 year after revision arthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| incidence surgical site infections | a. The proportion of SSI according to PREZIES (PREventie van ZIEkenhuisinfecties door Surveillance) criteria in both study groups during follow-up. | 1 year after revision arthroplasty |
| incidence periprosthetic joint infection |
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Inclusion Criteria:
Exclusion Criteria:
a. Previous allergic reaction according to the criteria in Appendix A. b. Severe kidney disease defined as eGFR <10 ml/min. f. Antimicrobial treatment within 3 days prior to index revision arthroplasty. g. Subjects who are currently enrolled in investigational immunosuppressive drug trials.
h. Subjects who are unable to provide informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Bart-Jan Kullberg, prof. Dr | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | Netherlands |
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randomized controled trial
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The proportion of PJI according to Philadelphia consensus definition 2018 in both study groups during follow-up. |
| 1 year after revision arthroplasty |
| resistance rate of causative of SSI/PJI to cefazolin | The cefazolin susceptibility of the micro-organisms causing SSI and PJI in the study groups. | 1 year after revision arthroplasty |
| The number of repeated surgeries. | The number of repeated surgeries. | 1 year after revision arthroplasty |
| Reason repeated surgery | The reason for repeated surgery on the affected prosthetic joint during follow-up. | 1 year after revision arthroplasty |
| adverse drug events | Adverse drug events and serious adverse events. | 1 year after revision arthroplasty |
| Risk factors associated with SSI and PJI: BMI, age, age of implant before revision, | Risk factors associated with SSI and PJI: BMI, age, age of implant before revision, number of previous revisions before index | 1 year after revision arthroplasty |
| Implant survival at the end of the study. | Implant survival at the end of the study. | during inclusion of the study |
| Patient related outcome measurements | PROMs at weeks 12 and 52 | 1 year after revision arthroplasty |
| ID | Term |
|---|---|
| D016459 | Prosthesis-Related Infections |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014946 | Wound Infection |
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| ID | Term |
|---|---|
| D002437 | Cefazolin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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