Evaluating XPERIENCE™ Advanced Surgical Irrigation

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• Inability or refusal to sign informed consent form
• Non-English or French speaking, and no licensed translator, family member or substitute decision maker available.
• Prior arthroplasty procedure to the affected joint
• Procedures involving solid HA implants
• Oncologic diagnosis to the affected joint.
• Non-TKA, THA or HR prosthesis (i.e., hemiarthroplasty, unicompartmental arthroplasty etc.)
• Allergy to any of the components of XP Advanced Surgical Irrigation
• Allergy to iodine
• 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.
• 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.
• Simultaneous bilateral total joint arthroplasty

Where this trial is running

• University of British Columbia, Vancouver, British Columbia, Canada
• London Health Sciences Center, London, Ontario, Canada
• The Ottawa Hospital, Ottawa, Ontario, Canada
• Humber River Health, Toronto, Ontario, Canada
• St. Joseph's Health Centre, Toronto, Ontario, Canada
• Hôpital Maisonneuve-Rosemont, Montreal, Quebec, Canada
• Jewish General Hospital, Montreal, Quebec, Canada
• CHU de Quebec-Université Laval, Québec, Quebec, Canada

Who to contact

Sanjula Costa · 613-737-8899 · scosta@ohri.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05543941.