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
About this trial
This is an interventional treatment trial for Hip Osteoarthritis
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.
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
NCT ID
NCT05543941
First Posted
September 13, 2022
Last Updated
September 13, 2022
Sponsor
Ottawa Hospital Research Institute
Collaborators
Next Science TM
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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