Evaluating XPERIENCE™ Advanced Surgical Irrigation

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Sep 13, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness of a new surgical irrigation method called XPERIENCE™ in preventing infections after major hip and knee surgeries, specifically total knee arthroplasty (TKA) and total hip arthroplasty (THA), as well as hip resurfacing. The study will compare this new method to a common alternative solution, dilute Betadine, to see which one helps reduce the risk of infections around the joint after surgery.

To be eligible for the trial, participants must be at least 18 years old and have certain types of arthritis or joint issues that require surgery. They should also be willing to follow the study guidelines and attend follow-up appointments. However, people with certain conditions, such as allergies to the study treatments or a history of specific joint infections, would not be able to participate. Those who join the trial can expect to receive either the XPERIENCE™ irrigation or the dilute Betadine during their surgery and will help researchers learn more about the best ways to keep patients safe from infections after these procedures.

Gender

ALL

Eligibility criteria

• 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. 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.
• • 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