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Recruiting NCT05543941

Evaluating XPERIENCE™ Advanced Surgical Irrigation

Trial Parameters

Condition Hip Osteoarthritis
Sponsor Ottawa Hospital Research Institute
Study Type INTERVENTIONAL
Phase N/A
Enrollment 7,600
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-04-01
Completion 2027-03-31
Interventions
XPERIENCE Advanced Surgical IrrigationDilute Betadine

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 (CD

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