Actively Recruiting
Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled Trial
Led by Ottawa Hospital Research Institute · Updated on 2026-05-28
7600
Participants Needed
8
Research Sites
39 weeks
Total Duration
On this page
Sponsors
O
Ottawa Hospital Research Institute
Lead Sponsor
O
OsteoRemedies, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the risk of periprosthetic joint infection (PJI) in patients undergoing primary total knee arthroplasty (TKA), total hip arthroplasty (THA), or hip resurfacing (HR). This randomized, controlled clinical trial compares two surgical irrigation methods: XPERIENCE™ Advanced Surgical Irrigation and dilute Betadine (DB). The study aims to better understand infection rates after these joint replacement surgeries. Participants will be randomly assigned to one of two groups. One group will receive the XPERIENCE Advanced Surgical Irrigation applied to the deep wound before closing the fascia, with the solution left to soak for up to 3 minutes. The other group will receive dilute Betadine solution prepared at 0.3% povidone-iodine concentration, applied similarly and soaked for up to 3 minutes, followed by rinsing with saline before wound closure. Both surgical sites will be closed according to standard procedures. This study is conducted across multiple centers. During the study, participants will be monitored for acute PJI within 90 days after surgery, with assessments at 2 weeks and 3 months. Secondary outcomes include rates of superficial wound infections, PJI at 1 year, wound complications requiring revision surgery, and patient-reported functional and quality of life scores before surgery and at 3 and 12 months post-surgery. Follow-up visits involve clinical evaluations and questionnaires to track recovery and infection status over one year.
CONDITIONS
Brief Title
Evaluating XPERIENCE™ Advanced Surgical Irrigation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 years or older
- Diagnosed with osteoarthritis, inflammatory arthritis, osteonecrosis, or post-traumatic arthritis in the affected joint
- Scheduled for primary total knee arthroplasty, total hip arthroplasty, or hip resurfacing
- Receiving either cemented or uncemented orthopedic implants
- Willing and able to sign written consent, follow study procedures, and attend follow-up visits
You will not qualify if you...
- Unable or unwilling to sign informed consent
- Non-English or French speaking without access to a licensed translator or substitute decision maker
- Prior joint replacement surgery on the affected joint
- Procedures involving solid hydroxyapatite implants
- Oncologic diagnosis affecting the joint
- Use of prostheses other than TKA, THA, or HR (e.g., hemiarthroplasty, unicompartmental arthroplasty)
- Allergy to any components of XPERIENCE Advanced Surgical Irrigation
- Allergy to iodine
- Active infection, primary immunodeficiency, uncontrolled HIV, immunomodulatory treatment for malignancy or autoimmune disease (except inflammatory arthritis), chronic steroid use of 20 mg prednisone daily or more for at least 1 month with another cause of immunosuppression, or organ/bone marrow transplantation
- History of septic arthritis in the affected joint within two years
- Steroid injection in the affected joint within three months before surgery
- Simultaneous bilateral total joint arthroplasty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo total hip arthroplasty, total knee arthroplasty, or hip resurfacing with the assigned surgical irrigation device applied prior to wound closure.
1 visit (in-person)
Duration - Up to 12 months after surgery
Participants attend follow-up visits to monitor for infections, wound complications, and to assess functional outcomes and quality of life.
Visits at 2 weeks, 3 months, and 12 months after surgery
Trial Site Locations
Total: 8 locations
1
University of British Columbia
Vancouver, British Columbia, Canada
Actively Recruiting
2
London Health Sciences Center
London, Ontario, Canada
Actively Recruiting
3
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
4
Humber River Health
Toronto, Ontario, Canada
Actively Recruiting
5
St. Joseph's Health Centre
Toronto, Ontario, Canada
Actively Recruiting
6
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Actively Recruiting
7
Jewish General Hospital
Montreal, Quebec, Canada
Actively Recruiting
8
CHU de Quebec-Université Laval
Québec, Quebec, Canada
Actively Recruiting
Research Team
S
Sanjula Costa
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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