Evaluating XPERIENCE™ Advanced Surgical Irrigation
Recruiting · NCT05543941 · Interventional (participants receive a specific treatment) · Lead sponsor: Ottawa Hospital Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Dilute BetadineXPERIENCE Advanced Surgical Irrigation
What this trial 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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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 it is running
8 locations listed.
- 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