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Evaluating XPERIENCE™ Advanced Surgical Irrigation (XPERIENCE)

Primary Purpose

Hip Osteoarthritis, Hip Arthritis, Knee Osteoarthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
XPERIENCE Advanced Surgical Irrigation
Dilute Betadine
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Chronic Immunosuppression (i.e. history of human immunodeficiency virus, treatment with immunosuppressive agent for cancer, solid organ transplant).
  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
  13. 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.
  14. Subjects with evidence of prolonged QT segment, per screening EKG.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    XPERIENCE Advanced Surgical Irrigation

    Dilute Betadine

    Arm Description

    Patients will receive the XPERIENCE Advanced Surgical Irrigation prior to wound closure.

    Patients will receive Dilute Betadine solution prior to wound closure.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Rate of Superficial Wound Infections
    Number of superficial wound infections
    Rate of PJI at 1 year
    Number of patients diagnosed with periprosthetic joint infections at 1 year 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))
    Patient Reported Functional Outcome Scores
    As measured by the Oxford Hip Score (OHS) or Oxford Knee Score (OKS)
    Patient Reported Quality of Life Scores
    As measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
    Wound Complications (non-infection) requiring revision surgery
    Number of patients requiring a revision surgery for a non-infection related wound complication

    Full Information

    First Posted
    September 13, 2022
    Last Updated
    September 13, 2022
    Sponsor
    Ottawa Hospital Research Institute
    Collaborators
    Next Science TM
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05543941
    Brief Title
    Evaluating XPERIENCE™ Advanced Surgical Irrigation
    Acronym
    XPERIENCE
    Official Title
    Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ottawa Hospital Research Institute
    Collaborators
    Next Science TM

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Osteoarthritis, Hip Arthritis, Knee Osteoarthritis, Knee Arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    7600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    XPERIENCE Advanced Surgical Irrigation
    Arm Type
    Experimental
    Arm Description
    Patients will receive the XPERIENCE Advanced Surgical Irrigation prior to wound closure.
    Arm Title
    Dilute Betadine
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive Dilute Betadine solution prior to wound closure.
    Intervention Type
    Device
    Intervention Name(s)
    XPERIENCE Advanced Surgical Irrigation
    Other Intervention Name(s)
    XP
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Dilute Betadine
    Other Intervention Name(s)
    DB, Providone-Iodine
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Rate of acute (<90 days post-surgery) PJI
    Description
    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.
    Time Frame
    2 weeks after surgery, 3 months after surgery, within 90 day of surgery
    Secondary Outcome Measure Information:
    Title
    Rate of Superficial Wound Infections
    Description
    Number of superficial wound infections
    Time Frame
    2 weeks after surgery
    Title
    Rate of PJI at 1 year
    Description
    Number of patients diagnosed with periprosthetic joint infections at 1 year after surgery
    Time Frame
    12 months after surgery
    Title
    Subgroup analysis of PJI rates for high-risk patients
    Description
    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))
    Time Frame
    3 months after surgery, 12 months after surgery
    Title
    Patient Reported Functional Outcome Scores
    Description
    As measured by the Oxford Hip Score (OHS) or Oxford Knee Score (OKS)
    Time Frame
    Before surgery, 3 months after surgery, 12 months after surgery
    Title
    Patient Reported Quality of Life Scores
    Description
    As measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
    Time Frame
    Before surgery, 3 months after surgery, 12 months after surgery
    Title
    Wound Complications (non-infection) requiring revision surgery
    Description
    Number of patients requiring a revision surgery for a non-infection related wound complication
    Time Frame
    2 weeks after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Meaghan Dufresne
    Phone
    613-737-8899
    Ext
    74711
    Email
    meadufresne@ohri.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Simon Garceau, MD
    Organizational Affiliation
    The Ottawa Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No IPD will be made available to other researchers

    Learn more about this trial

    Evaluating XPERIENCE™ Advanced Surgical Irrigation

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