Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05543941

Evaluating XPERIENCE™ Advanced Surgical Irrigation

Led by Ottawa Hospital Research Institute · Updated on 2025-08-13

7600

Participants Needed

9

Research Sites

247 weeks

Total Duration

On this page

Sponsors

O

Ottawa Hospital Research Institute

Lead Sponsor

N

Next Science TM

Collaborating Sponsor

AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

Evaluating XPERIENCE™ Advanced Surgical Irrigation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients aged 18 years or older
  • Diagnosis of osteoarthritis, inflammatory arthritis, osteonecrosis, or post-traumatic arthritis to the affected joint
  • Undergoing primary total knee arthroplasty, total hip arthroplasty, or hip resurfacing
  • Receiving either cemented or uncemented orthopedic implants
  • Willing and able to sign written consent, follow the study protocol, and attend follow-up visits
Not Eligible

You will not qualify if you...

  • Unable or unwilling to sign informed consent
  • Non-English or French speaking without a licensed translator, family member, or substitute decision maker available
  • Previous arthroplasty procedure on the affected joint
  • Procedures involving solid hydroxyapatite implants
  • Oncologic diagnosis related to the affected joint
  • Use of non-TKA, THA, or HR prosthesis (e.g., hemiarthroplasty, unicompartmental arthroplasty)
  • Allergy to any component of XPERIENCE Advanced Surgical Irrigation
  • Allergy to iodine
  • Presence of active infection, primary immunodeficiency, uncontrolled HIV (CD4 <200 cells/uL), immunomodulatory treatment for malignancy or autoimmune disease (except inflammatory arthritis), chronic glucocorticosteroid use (≥20 mg prednisone daily for at least 1 month with another cause of immunosuppression), or solid organ/bone marrow transplantation
  • History of septic arthritis in the affected joint within two years before surgery
  • History of steroid injection in the affected joint within three months before surgery
  • Undergoing simultaneous bilateral total joint arthroplasty

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

University of British Columbia

Vancouver, British Columbia, Canada

Not Yet Recruiting

2

London Health Sciences Center

London, Ontario, Canada

Actively Recruiting

3

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

4

Humber River Health

Toronto, Ontario, Canada

Not Yet Recruiting

5

St. Joseph's Health Centre

Toronto, Ontario, Canada

Actively Recruiting

6

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Not Yet Recruiting

7

Jewish General Hospital

Montreal, Quebec, Canada

Not Yet Recruiting

8

McGill University

Montreal, Quebec, Canada

Not Yet Recruiting

9

CHU de Quebec-Université Laval

Québec, Quebec, Canada

Not Yet Recruiting

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Research Team

S

Sanjula Costa

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Evaluating XPERIENCE™ Advanced Surgical Irrigation | DecenTrialz