Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled Trial
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male and female patients aged 18 years or older
• Diagnosis of osteoarthritis, inflammatory arthritis, osteonecrosis, or post-traumatic arthritis 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
Locations
Other Locations
Canada
London Health Sciences Center
RECRUITING
London
Hôpital Maisonneuve-Rosemont
NOT_YET_RECRUITING
Montreal
Jewish General Hospital
NOT_YET_RECRUITING
Montreal
McGill University
NOT_YET_RECRUITING
Montreal
The Ottawa Hospital
RECRUITING
Ottawa
CHU de Quebec-Université Laval
NOT_YET_RECRUITING
Québec
Humber River Health
NOT_YET_RECRUITING
Toronto
St. Joseph's Health Centre
RECRUITING
Toronto
University of British Columbia
NOT_YET_RECRUITING
Vancouver
Contact Information
Primary
Sanjula Costa
scosta@ohri.ca
613-737-8899
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 7600
Treatments
Experimental: XPERIENCE Advanced Surgical Irrigation
Patients will receive the XPERIENCE Advanced Surgical Irrigation prior to wound closure.
Active_comparator: Dilute Betadine
Patients will receive Dilute Betadine solution prior to wound closure.
Related Therapeutic Areas
Sponsors
Collaborators: Next Science TM
Leads: Ottawa Hospital Research Institute