Evaluating XPERIENCE™ Advanced Surgical Irrigation

Last updated: April 2, 2024
Sponsor: Ottawa Hospital Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Joint Injuries

Knee Injuries

Treatment

Dilute Betadine

XPERIENCE Advanced Surgical Irrigation

Clinical Study ID

NCT05543941
ISR-0104
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Male and female patients aged 18 years or older
  2. Diagnosis of osteoarthritis, inflammatory arthritis, osteonecrosis, or post-traumaticarthritis 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

Exclusion Criteria:

  1. Inability or refusal to sign informed consent form
  2. Non-English or French speaking, and no licensed translator, family member orsubstitute 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 arthroplastyetc.)
  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 ofuncontrolled HIV (CD4 count <200 cells/uL), treatment with immunomodulatorymedications for malignancy or autoimmune disease (with exception to inflammatoryarthritis), chronic glucocorticosteroid use (≥20 mg of prednisone daily for at least 1month with another cause of immunosuppression), and solid organ and/or bone marrowtransplantation.
  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 precedingsurgery.
  12. Simultaneous bilateral total joint arthroplasty

Study Design

Total Participants: 7600
Treatment Group(s): 2
Primary Treatment: Dilute Betadine
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • University of British Columbia

    Vancouver, British Columbia
    Canada

    Site Not Available

  • London Health Sciences Center

    London, Ontario
    Canada

    Active - Recruiting

  • The Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Humber River Health

    Toronto, Ontario
    Canada

    Site Not Available

  • St. Joseph's Health Centre

    Toronto, Ontario
    Canada

    Active - Recruiting

  • Hôpital Maisonneuve-Rosemont

    Montréal, Quebec
    Canada

    Site Not Available

  • Jewish General Hospital

    Montréal, Quebec
    Canada

    Site Not Available

  • McGill University

    Montréal, Quebec
    Canada

    Site Not Available

  • CHU de Quebec-Université Laval

    Québec, Quebec
    Canada

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.