Evaluating XPERIENCE™ Advanced Surgical Irrigation (XPERIENCE)

Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Hip Osteoarthritis; Knee Arthritis; Hip Arthritis
• Intervention / Treatment: Device: XPERIENCE Advanced Surgical Irrigation; Device: Dilute Betadine

• Study Type: Interventional
• Enrollment (Estimated): 7600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sanjula Costa; Phone Number: 72640 613-737-8899; Email: scosta@ohri.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Recruiting
      • University of British Columbia
      • Principal Investigator: Michael Neufeld, MD
      • Contact: Kelsey Lee; Email: kelsey.lee@vch.ca
  • Ontario
    • London, Ontario, Canada
      • Recruiting
      • London Health Sciences Center
      • Principal Investigator: Brent Lanting, MD
      • Contact: Abbigail Allen; Phone Number: 37843 519-685-8500; Email: Abbigail.Allen@lhsc.on.ca
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital
      • Principal Investigator: Simon Garceau, MD
      • Contact: Sanjula Costa; Phone Number: 72640 613-737-8899; Email: scosta@ohri.ca
    • Toronto, Ontario, Canada
      • Recruiting
      • St. Joseph's Health Centre
      • Contact: Carlos Fernando; Phone Number: 416-864-6060 x 46969; Email: Carlos.Fernando@unityhealth.to
      • Principal Investigator: George Vincent, MD
    • Toronto, Ontario, Canada
      • Recruiting
      • Humber River Health
      • Contact: Michele Petrovic; Phone Number: 81263 416-242-1000; Email: MPetrovic@hrh.ca
      • Principal Investigator: Sebastian Rodriguez-Elizalde, MD
  • Quebec
    • Montreal, Quebec, Canada
      • Recruiting
      • Jewish General Hospital
      • Contact: Laura Epure; Email: laura.epure@mcgill.ca
      • Principal Investigator: John Antoniou, MD
    • Montreal, Quebec, Canada
      • Recruiting
      • Hôpital Maisonneuve-Rosemont
      • Contact: Serge Marquis; Phone Number: 5701 514-252-3400; Email: smarquis.hmr@ssss.gouv.qc.ca
      • Contact: Janie Barry; Email: jbarry.hmr@ssss.gouv.qc.ca
      • Principal Investigator: Alexandre Benny, MD
    • Québec, Quebec, Canada
      • Recruiting
      • CHU de Quebec-Universite Laval
      • Principal Investigator: Etienne Belzile, MD
      • Contact: Sylvie Turmel; Phone Number: 66175 418-525-4444; Email: turmel.sylvie@chudequebec.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XPERIENCE Advanced Surgical Irrigation; Patients will receive the XPERIENCE Advanced Surgical Irrigation prior to wound closure.	Device: XPERIENCE Advanced Surgical Irrigation; 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.; Other Names: XP
Active Comparator: Dilute Betadine; Patients will receive Dilute Betadine solution prior to wound closure.	Device: Dilute Betadine; 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.; Other Names: DB; Providone-Iodine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks after surgery, 3 months after surgery, within 90 day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Superficial Wound Infections	Number of superficial wound infections	2 weeks after surgery
Rate of PJI at 1 year	Number of patients diagnosed with periprosthetic joint infections at 1 year after surgery	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))	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)	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)	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	2 weeks after surgery

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: OsteoRemedies, LLC
• Investigators: Principal Investigator: Simon Garceau, MD, The Ottawa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Anti-Infective Agents; Anti-Infective Agents, Local; Povidone-Iodine
• Other Study ID Numbers: ISR-0104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be made available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes