Evaluating XPERIENCE™ Advanced Surgical Irrigation

Ottawa Hospital Research Institute

Status: Enrolling

Conditions: Knee Arthritis; Hip Osteoarthritis; Hip Arthritis; Knee Osteoarthritis

Treatments: Device: XPERIENCE Advanced Surgical Irrigation; Device: Dilute Betadine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05543941

ISR-0104

Details and patient eligibility

About

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).

Enrollment: 7,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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7,600 participants in 2 patient groups

XPERIENCE Advanced Surgical Irrigation

Experimental group

Description:

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

Treatment:

Device: XPERIENCE Advanced Surgical Irrigation

Dilute Betadine

Active Comparator group

Description:

Patients will receive Dilute Betadine solution prior to wound closure.

Treatment:

Device: Dilute Betadine