NCT05543941RecruitingNot Applicable
Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled Trial
Ottawa Hospital Research Institute19 sites in 1 country7,600 target enrollmentStarted: April 1, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 7,600
- Locations
- 19
- Primary Endpoint
- Rate of acute (<90 days post-surgery) PJI
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Inability or refusal to sign informed consent form
- •Non-English or French speaking, and no licensed translator, family member or substitute 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 arthroplasty etc.)
- •Allergy to any of the components of XP Advanced Surgical Irrigation
- •Allergy to iodine
- •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.
- •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 preceding surgery.
- •Simultaneous bilateral total joint arthroplasty
Arms & Interventions
XPERIENCE Advanced Surgical Irrigation
Experimental
Patients will receive the XPERIENCE Advanced Surgical Irrigation prior to wound closure.
Intervention: XPERIENCE Advanced Surgical Irrigation (Device)
Dilute Betadine
Active Comparator
Patients will receive Dilute Betadine solution prior to wound closure.
Intervention: Dilute Betadine (Device)
Outcomes
Primary Outcomes
Rate of acute (<90 days post-surgery) PJI
Time Frame: 2 weeks after surgery, 3 months after surgery, within 90 day of surgery
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.
Secondary Outcomes
- Patient Reported Quality of Life Scores(Before surgery, 3 months after surgery, 12 months after surgery)
- Subgroup analysis of PJI rates for high-risk patients(3 months after surgery, 12 months after surgery)
- Rate of PJI at 1 year(12 months after surgery)
- Patient Reported Functional Outcome Scores(Before surgery, 3 months after surgery, 12 months after surgery)
- Rate of Superficial Wound Infections(2 weeks after surgery)
- Wound Complications (non-infection) requiring revision surgery(2 weeks after surgery)
Investigators
Study Sites (19)
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