Clinical trial NCT05543941: Evaluating XPERIENCE™ Advanced Surgical Irrigation
Official title: Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Hip Arthritis
Knee Osteoarthritis
Knee Arthritis
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Next Science TM
First posted: 2022-09-16
Enrollment: 7600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Rate of acute (<90 days post-surgery) PJI
timeFrame: 2 weeks after surgery, 3 months after surgery, within 90 day of surgery
Secondary outcomes:
measure: Rate of Superficial Wound Infections
timeFrame: 2 weeks after surgery
measure: Rate of PJI at 1 year
timeFrame: 12 months after surgery
measure: Subgroup analysis of PJI rates for high-risk patients
timeFrame: 3 months after surgery, 12 months after surgery
measure: Patient Reported Functional Outcome Scores
timeFrame: Before surgery, 3 months after surgery, 12 months after surgery
measure: Patient Reported Quality of Life Scores
timeFrame: Before surgery, 3 months after surgery, 12 months after surgery
measure: Wound Complications (non-infection) requiring revision surgery
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Humber River Health
state: Ontario
city: Toronto
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: McGill University
state: Quebec
city: Québec
country: Canada
facility: CHU de Quebec-Université Laval
state: Quebec
Study officials:
affiliation: The Ottawa Hospital
name: Simon Garceau, MD
role: PRINCIPAL_INVESTIGATOR
References: