Health Trials

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • XPERIENCE Advanced Surgical Irrigation
  • Dilute Betadine

Treatment groups

7,600 Participants
are divided into 2 treatment groups

Locations

8
University of British Columbia VancouverBritish Columbia, Canada
London Health Sciences Center LondonOntario, Canada
The Ottawa HospitalK1H 8L6, OttawaOntario, Canada
Humber River Health TorontoOntario, Canada

Sponsors and collaborators

Ottawa Hospital Research Institute

Lead sponsor

OsteoRemedies, LLC

Collaborator

Source ClinicalTrials.gov