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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male and female patients aged 18 years or older
- Diagnosis of osteoarthritis, inflammatory arthritis, osteonecrosis, or post-traumaticarthritis to the affected joint.
- Primary TKA, THA, and HR
- Subjects receiving both cemented or uncemented orthopaedic implants
- Willing and able to sign written consent, follow study protocol and attend follow-up
Exclusion
Exclusion Criteria:
- Inability or refusal to sign informed consent form
- Non-English or French speaking, and no licensed translator, family member orsubstitute decision maker available.
- Prior arthroplasty procedure to the affected joint
- Procedures involving solid HA implants
- Oncologic diagnosis to the affected joint.
- Non-TKA, THA or HR prosthesis (i.e., hemiarthroplasty, unicompartmental arthroplastyetc.)
- Allergy to any of the components of XP Advanced Surgical Irrigation
- Allergy to iodine
- 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.
- History of septic arthritis to the affected joint within two years of surgery(1).
- History of steroid injection to the affected joint within the three months precedingsurgery.
- 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
CanadaSite Not Available
London Health Sciences Center
London, Ontario
CanadaActive - Recruiting
The Ottawa Hospital
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
Humber River Health
Toronto, Ontario
CanadaSite Not Available
St. Joseph's Health Centre
Toronto, Ontario
CanadaActive - Recruiting
Hôpital Maisonneuve-Rosemont
Montréal, Quebec
CanadaSite Not Available
Jewish General Hospital
Montréal, Quebec
CanadaSite Not Available
McGill University
Montréal, Quebec
CanadaSite Not Available
CHU de Quebec-Université Laval
Québec, Quebec
CanadaSite 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.