Evaluating XPERIENCE™ Advanced Surgical Irrigation

Study Overview
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Brief Summary
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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).

Official Title
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Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled Trial

Conditions
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Hip Osteoarthritis, Hip Arthritis, Knee Osteoarthritis, Knee Arthritis

Intervention / Treatment
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* Device: Dilute Betadine
* Device: XPERIENCE Advanced Surgical Irrigation


Participation Criteria
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Eligibility Criteria
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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 Chronic Immunosuppression (i.e. history of human immunodeficiency virus, treatment with immunosuppressive agent for cancer, solid organ transplant). 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 Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Subjects with evidence of prolonged QT segment, per screening EKG.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XPERIENCE Advanced Surgical Irrigation<br>Patients will receive the XPERIENCE Advanced Surgical Irrigation prior to wound closure. | Device: XPERIENCE Advanced Surgical Irrigation<br>* The patient will undergo THA, TKA, or HR with irrigation of the deep wound prior to fascial closure consisting of XPERIENCE Advanced Surgical Irrigation (XP). XP solution will be applied prior to fascial closure and left to soak for up to 3 minutes. Remaining product will be suctioned away throughout the procedure. No rinsing should take place after irrigation and surgical site will be closed according to site standard operating procedures.<br>* Other names: XP;|
| Active Comparator: Dilute Betadine<br>Patients will receive Dilute Betadine solution prior to wound closure. | Device: Dilute Betadine<br>* The patient will undergo THA, HR or TKA with irrigation of the deep wound prior to fascial closure consisting of Dilute Betadine (DB). DB concentration will be standardized at 0.3% povidone-iodine. DB will be prepared by combining 30 mL of sterile 10% povidone-iodine (from a sterile catheter pack) with 1 L of 0.9% saline in a sterile splash basin. Solution will be left to soak for up to 3 minutes and remaining povidone-iodine solution will be suctioned away. Area will then be rinsed with 1L of normal saline. Surgical site will be closed according to site standard operating procedures.<br>* Other names: Providone-Iodine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of acute (<90 days post-surgery) PJI | 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. | 2 weeks after surgery, 3 months after surgery, within 90 day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Superficial Wound Infections | Number of superficial wound infections | 2 weeks after surgery | 
| Rate of PJI at 1 year | Number of patients diagnosed with periprosthetic joint infections at 1 year after surgery | 12 months after surgery | 
| Subgroup analysis of PJI rates for high-risk patients | Number of patients diagnosed with PJI at 3 months and 1 year in higher risk patient categories (morbid obesity (BMI >40kg/m2), diabetes mellitus, chronic kidney disease, inflammatory arthritis, active smokers (nicotine)) | 3 months after surgery, 12 months after surgery | 
| Patient Reported Functional Outcome Scores | As measured by the Oxford Hip Score (OHS) or Oxford Knee Score (OKS) | Before surgery, 3 months after surgery, 12 months after surgery | 
| Patient Reported Quality of Life Scores | As measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) | Before surgery, 3 months after surgery, 12 months after surgery | 
| Wound Complications (non-infection) requiring revision surgery | Number of patients requiring a revision surgery for a non-infection related wound complication | 2 weeks after surgery |