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NCT Number: NCT05543941

Evaluating XPERIENCE™ Advanced Surgical Irrigation

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).

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Key information

Conditions

Hip Osteoarthritis Arthritis Hip Arthritis Joint Diseases Knee Arthritis Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XPERIENCE Advanced Surgical Irrigation

Device

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.

Other names: XP

Dilute Betadine

Device

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.

Other names: DB, Providone-Iodine

Primary outcomes

  1. 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

  1. Rate of Superficial Wound Infections

    Time frame: 2 weeks after surgery

    Number of superficial wound infections

  2. Rate of PJI at 1 year

    Time frame: 12 months after surgery

    Number of patients diagnosed with periprosthetic joint infections at 1 year after surgery

  3. Subgroup analysis of PJI rates for high-risk patients

    Time frame: 3 months after surgery, 12 months after surgery

    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))

  4. Patient Reported Functional Outcome Scores

    Time frame: Before surgery, 3 months after surgery, 12 months after surgery

    As measured by the Oxford Hip Score (OHS) or Oxford Knee Score (OKS)

  5. Patient Reported Quality of Life Scores

    Time frame: Before surgery, 3 months after surgery, 12 months after surgery

    As measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)

  6. Wound Complications (non-infection) requiring revision surgery

    Time frame: 2 weeks after surgery

    Number of patients requiring a revision surgery for a non-infection related wound complication

Study contacts

Contact information is provided by the study sponsor or research team.

Sanjula Costa

CONTACT

[email protected]

613-737-8899 ext. 72640

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • OsteoRemedies, LLC

Registry information

Official study title

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

Acronym: XPERIENCE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2022
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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