Evaluating XPERIENCE™ Advanced Surgical Irrigation
Knee Osteoarthritis | Hip Osteoarthritis | Knee Arthritis | Hip ArthritisA 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).
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation 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
Study Location
The Ottawa Hospital
The Ottawa HospitalOttawa, Ontario
Canada
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Jewish General Hospital
Jewish General HospitalMontréal, Quebec
Canada
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London Health Sciences Center
London Health Sciences CenterLondon, Ontario
Canada
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Hôpital Maisonneuve-Rosemont
Hôpital Maisonneuve-RosemontMontréal, Quebec
Canada
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Humber River Health
Humber River HealthToronto, Ontario
Canada
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McGill University
McGill UniversityMontréal, Quebec
Canada
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University of British Columbia
University of British ColumbiaVancouver, British Columbia
Canada
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St. Joseph's Health Centre
St. Joseph's Health CentreToronto, Ontario
Canada
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CHU de Quebec-Université Laval
CHU de Quebec-Université LavalQuébec, Quebec
Canada
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- Study Sponsored By
- Ottawa Hospital Research Institute
- Participants Required
- More Information
- Study ID:
NCT05543941