Recruiting

XPERIENCE™

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05543941

Conditions

Hip Osteoarthritis

Hip Arthritis

Knee Osteoarthritis

Knee Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

XPERIENCE Advanced Surgical Irrigation

Dilute Betadine

Study Details

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).

Conditions

Hip Osteoarthritis

Hip Arthritis

Knee Osteoarthritis

Knee Arthritis

Study ID

NCT05543941

Start date

Apr 1, 2023

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

7600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: XPERIENCE Advanced Surgical Irrigation

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

active comparator: Dilute Betadine

Patients will receive Dilute Betadine solution prior to wound closure.

Interventions

XPERIENCE 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.

Dilute 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.

Primary outcome measure

  • Rate of acute (<90 days post-surgery) PJI [ Time Frame: 2 weeks after surgery, 3 months after surgery, within 90 day of surgery ]

Central Contacts and Locations

Central contacts

Locations

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada

Contacts

Principal Investigator:

Michael Neufeld, MD

London Health Sciences Center

Recruiting

London, Ontario, Canada

Contacts

Principal Investigator:

Brent Lanting, MD

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Principal Investigator:

Simon Garceau, MD

Humber River Health

Recruiting

Toronto, Ontario, Canada

Contacts

Principal Investigator:

Sebastian Rodriguez-Elizalde, MD

St. Joseph's Health Centre

Recruiting

Toronto, Ontario, Canada

Contacts

Principal Investigator:

George Vincent, MD

Hôpital Maisonneuve-Rosemont

Recruiting

Montreal, Quebec, Canada

Contacts

Principal Investigator:

Alexandre Benny, MD

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada

Contacts

Principal Investigator:

John Antoniou, MD

CHU de Quebec-Université Laval

Recruiting

Québec, Quebec, Canada

Contacts

Principal Investigator:

Etienne Belzile, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

May 28, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-05-28.