RecruitingNot ApplicableNCT05543941

Evaluating XPERIENCE™ Advanced Surgical Irrigation

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

Sponsor

Ottawa Hospital Research Institute

Enrollment

7,600 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis hip osteoarthritis Hip Arthritis Knee arthritis

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria12

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

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Interventions

DEVICEXPERIENCE Advanced Surgical Irrigation

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.

DEVICEDilute Betadine

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.