Evaluating XPERIENCE™ Advanced Surgical Irrigation
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Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Ottawa Hospital Research Institute
- Azonosító
- NCT05543941
- A regiszteradat frissítve
- 2026. május 28.
- Eredeti leírás
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).A teljes eredeti leírásKevesebb
Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled Trial
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).
Bevonási feltételek: Male and female patients aged 18 years or older; Diagnosis of osteoarthritis, inflammatory arthritis, osteonecrosis, or post-traumatic arthritis to the affected joint; Primary TKA, THA, and HR; Subjects receiving both cemented or uncemented orthopaedic implants; Willing and able to sign written consent, follow study protocol and attend follow-up.
Kizáró feltételek: Prior arthroplasty procedure to the affected joint; Procedures involving solid HA implants; Allergy to any of the components of XP Advanced Surgical Irrigation; Allergy to iodine; History of septic arthritis to the affected joint within two years of surgery(1); History of steroid injection to the affected joint within the three months preceding surgery; Presence of concurrent active infection, primary immunodeficiency, history of uncontrolled HIV (CD4 count <200 cells/uL), treatment with immunomodulatory medications for malignancy or autoimmune disease (with exception to inflammatory arthritis), chronic glucocorticosteroid use (≥20 mg of prednisone daily for at least 1 month with another cause of immunosuppression), and solid organ and/or bone marrow transplantation; Inability or refusal to sign informed consent form; Non-English or French speaking, and no licensed translator, family member or substitute decision maker available; Oncologic diagnosis to the affected joint; Non-TKA, THA or HR prosthesis (i.e., hemiarthroplasty, unicompartmental arthroplasty etc.); Simultaneous bilateral total joint arthroplasty.