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| Name | Class |
|---|---|
| OsteoRemedies, LLC | INDUSTRY |
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A prospective, multi-center, double-arm, parallel, interventional, randomized, controlled clinical trial to assess the rate of periprosthetic joint infection (PJI) in patients undergoing primary total knee arthroplasty (TKA), total hip arthroplasty (THA) or hip resurfacing (HR) with XPERIENCE™ (XP) Advanced Surgical Irrigation versus dilute Betadine (DB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XPERIENCE Advanced Surgical Irrigation | Experimental | Patients will receive the XPERIENCE Advanced Surgical Irrigation prior to wound closure. |
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| Dilute Betadine | Active Comparator | Patients will receive Dilute Betadine solution prior to wound closure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XPERIENCE Advanced Surgical Irrigation | Device | The patient will undergo THA, TKA, or HR with irrigation of the deep wound prior to fascial closure consisting of XPERIENCE Advanced Surgical Irrigation (XP). XP solution will be applied prior to fascial closure and left to soak for up to 3 minutes. Remaining product will be suctioned away throughout the procedure. No rinsing should take place after irrigation and surgical site will be closed according to site standard operating procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of acute (<90 days post-surgery) PJI | Number of patients diagnosed with periprosthetic joint infection as per the diagnostic criteria outlined by the 2018 International Consensus Meeting of the Musculoskeletal Infection Society for Acute PJI. | 2 weeks after surgery, 3 months after surgery, within 90 day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Superficial Wound Infections | Number of superficial wound infections | 2 weeks after surgery |
| Rate of PJI at 1 year | Number of patients diagnosed with periprosthetic joint infections at 1 year after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanjula Costa | Contact | 613-737-8899 | 72640 | scosta@ohri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Simon Garceau, MD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Recruiting | Vancouver | British Columbia | Canada |
No IPD will be made available to other researchers
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Dilute Betadine | Device | The patient will undergo THA, HR or TKA with irrigation of the deep wound prior to fascial closure consisting of Dilute Betadine (DB). DB concentration will be standardized at 0.3% povidone-iodine. DB will be prepared by combining 30 mL of sterile 10% povidone-iodine (from a sterile catheter pack) with 1 L of 0.9% saline in a sterile splash basin. Solution will be left to soak for up to 3 minutes and remaining povidone-iodine solution will be suctioned away. Area will then be rinsed with 1L of normal saline. Surgical site will be closed according to site standard operating procedures. |
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| 12 months after surgery |
| Subgroup analysis of PJI rates for high-risk patients | Number of patients diagnosed with PJI at 3 months and 1 year in higher risk patient categories (morbid obesity (BMI >40kg/m2), diabetes mellitus, chronic kidney disease, inflammatory arthritis, active smokers (nicotine)) | 3 months after surgery, 12 months after surgery |
| Patient Reported Functional Outcome Scores | As measured by the Oxford Hip Score (OHS) or Oxford Knee Score (OKS) | Before surgery, 3 months after surgery, 12 months after surgery |
| Patient Reported Quality of Life Scores | As measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) | Before surgery, 3 months after surgery, 12 months after surgery |
| Wound Complications (non-infection) requiring revision surgery | Number of patients requiring a revision surgery for a non-infection related wound complication | 2 weeks after surgery |
| London Health Sciences Center | Recruiting | London | Ontario | Canada |
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| The Ottawa Hospital | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
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| Humber River Health | Recruiting | Toronto | Ontario | Canada |
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| St. Joseph's Health Centre | Recruiting | Toronto | Ontario | Canada |
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| Hôpital Maisonneuve-Rosemont | Recruiting | Montreal | Quebec | Canada |
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| Jewish General Hospital | Recruiting | Montreal | Quebec | Canada |
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| CHU de Quebec-Université Laval | Recruiting | Québec | Quebec | Canada |
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| D012216 |
| Rheumatic Diseases |