Evaluating a new surgical irrigation method for joint replacement surgeries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is designed to compare the effectiveness of XPERIENCE™ Advanced Surgical Irrigation against dilute Betadine in preventing periprosthetic joint infections in patients undergoing total knee or hip arthroplasty. It is a prospective, multi-center, double-arm, parallel, interventional, randomized, controlled trial. Participants will be randomly assigned to receive either the new irrigation method or the standard treatment during their surgery. The study aims to gather data on infection rates post-surgery to determine if the new method offers significant advantages.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male and female patients aged 18 years or older
2. Diagnosis of osteoarthritis, inflammatory arthritis, osteonecrosis, or post-traumatic arthritis to the affected joint.
3. Primary TKA, THA, and HR
4. Subjects receiving both cemented or uncemented orthopaedic implants
5. Willing and able to sign written consent, follow study protocol and attend follow-up

Exclusion Criteria:

1. Inability or refusal to sign informed consent form
2. Non-English or French speaking, and no licensed translator, family member or substitute decision maker available.
3. Prior arthroplasty procedure to the affected joint
4. Procedures involving solid HA implants
5. Oncologic diagnosis to the affected joint.
6. Non-TKA, THA or HR prosthesis (i.e., hemiarthroplasty, unicompartmental arthroplasty etc.)
7. Allergy to any of the components of XP Advanced Surgical Irrigation
8. Allergy to iodine
9. 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.
10. History of septic arthritis to the affected joint within two years of surgery(1).
11. History of steroid injection to the affected joint within the three months preceding surgery.
12. Simultaneous bilateral total joint arthroplasty

Where it's running

• University of British Columbia
  Vancouver, British Columbia, Canada Recruiting
• London Health Sciences Center
  London, Ontario, Canada Recruiting
• The Ottawa Hospital
  Ottawa, Ontario, Canada Recruiting
• Humber River Health
  Toronto, Ontario, Canada Recruiting
• St. Joseph's Health Centre
  Toronto, Ontario, Canada Recruiting
• Hôpital Maisonneuve-Rosemont
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Simon Garceau, MD — The Ottawa Hospital
• Study coordinator: Sanjula Costa
• Email: scosta@ohri.ca
• Phone: 613-737-8899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.