Evaluating a new surgical irrigation method for joint replacement surgeries

Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled Trial

This study is testing a new way to clean the surgical area during knee or hip replacement surgeries to see if it can lower the risk of infections compared to the usual method.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 7600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Hospital Research Institute (other)
• Drugs / interventions: prednisone
• Locations: 9 sites (Vancouver, British Columbia and 8 other locations)
• Trial ID: NCT05543941 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with osteoarthritis or other specified joint conditions who are scheduled for total knee or hip arthroplasty.

Not a fit: Patients who have had prior surgeries on the affected joint or have specific allergies or infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a reduction in joint infections following major orthopedic surgeries, improving patient outcomes.

How similar studies have performed: Other studies have explored various irrigation methods in surgical settings, but the specific use of XPERIENCE™ Advanced Surgical Irrigation in this context is relatively novel.

Eligibility criteria

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 this trial is running

Vancouver, British Columbia and 8 other locations

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

Study contacts

• Principal investigator: Simon Garceau, MD — The Ottawa Hospital
• Study coordinator: Sanjula Costa

Conditions: Hip Osteoarthritis, Hip Arthritis, Knee Osteoarthritis, Knee Arthritis