NCT05543941 Evaluating XPERIENCE™ Advanced Surgical Irrigation
| NCT ID | NCT05543941 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | Hip Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 7,600 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 7,600 participants in total. It began in 2023-04-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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
Contact & Investigator
Simon Garceau, MD
PRINCIPAL INVESTIGATOR
The Ottawa Hospital
Frequently Asked Questions
Who can join the NCT05543941 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hip Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05543941 currently recruiting?
Yes, NCT05543941 is actively recruiting participants. Contact the research team at scosta@ohri.ca for enrollment information.
Where is the NCT05543941 trial being conducted?
This trial is being conducted at Vancouver, Canada, London, Canada, Ottawa, Canada, Toronto, Canada and 5 additional locations.
Who is sponsoring the NCT05543941 clinical trial?
NCT05543941 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Simon Garceau, MD at The Ottawa Hospital. The trial plans to enroll 7,600 participants.