An interventional study of XPERIENCE Advanced Surgical Irrigation and Dilute Betadine in Hip Osteoarthritis, Hip Arthritis and Knee Osteoarthritis, sponsored by Ottawa Hospital Research Institute. Recruiting at 8 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Treatment
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).
628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.
This study's planned enrollment of 7,600 is above the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
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Exclusion Criteria:
Patients will receive the XPERIENCE Advanced Surgical Irrigation prior to wound closure.
Device: XPERIENCE Advanced Surgical Irrigation
Patients will receive Dilute Betadine solution prior to wound closure.
Device: Dilute Betadine
The patient will undergo THA, TKA, or HR with irrigation of the deep wound prior to fascial closure consisting of XPERIENCE Advanced Surgical Irrigation (XP). XP solution will be applied prior to fascial closure and left to soak for up to 3 minutes. Remaining product will be suctioned away throughout the procedure. No rinsing should take place after irrigation and surgical site will be closed according to site standard operating procedures.
Also known as: XP
The patient will undergo THA, HR or TKA with irrigation of the deep wound prior to fascial closure consisting of Dilute Betadine (DB). DB concentration will be standardized at 0.3% povidone-iodine. DB will be prepared by combining 30 mL of sterile 10% povidone-iodine (from a sterile catheter pack) with 1 L of 0.9% saline in a sterile splash basin. Solution will be left to soak for up to 3 minutes and remaining povidone-iodine solution will be suctioned away. Area will then be rinsed with 1L of normal saline. Surgical site will be closed according to site standard operating procedures.
Also known as: DB, Providone-Iodine
Rate of acute (<90 days post-surgery) PJI
Number of patients diagnosed with periprosthetic joint infection as per the diagnostic criteria outlined by the 2018 International Consensus Meeting of the Musculoskeletal Infection Society for Acute PJI.
Time frame: 2 weeks after surgery, 3 months after surgery, within 90 day of surgery
Rate of Superficial Wound Infections
Number of superficial wound infections
Time frame: 2 weeks after surgery
Rate of PJI at 1 year
Number of patients diagnosed with periprosthetic joint infections at 1 year after surgery
Time frame: 12 months after surgery
Subgroup analysis of PJI rates for high-risk patients
Number of patients diagnosed with PJI at 3 months and 1 year in higher risk patient categories (morbid obesity (BMI \>40kg/m2), diabetes mellitus, chronic kidney disease, inflammatory arthritis, active smokers (nicotine))
Time frame: 3 months after surgery, 12 months after surgery
Patient Reported Functional Outcome Scores
As measured by the Oxford Hip Score (OHS) or Oxford Knee Score (OKS)
Time frame: Before surgery, 3 months after surgery, 12 months after surgery
Patient Reported Quality of Life Scores
As measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: Before surgery, 3 months after surgery, 12 months after surgery
Wound Complications (non-infection) requiring revision surgery
Number of patients requiring a revision surgery for a non-infection related wound complication
Time frame: 2 weeks after surgery
Plan to share: No — No IPD will be made available to other researchers
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Ottawa Hospital Research Institute