No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
7,600 (estimated)
Sponsor
Ottawa Hospital Research Institute · Other
Who this trial is looking for
This trial is looking for patients with knee or hip arthritis who are planning to have joint replacement surgery. Participants will receive a specific type of irrigation during their surgery to see if it helps reduce infections.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I have been diagnosed with knee or hip arthritis
I am planning to have a total knee or hip replacement surgery
I can agree to follow study rules and attend follow-up visits
You may not be able to join if
I cannot sign the consent form
I have had previous surgery on the same joint
I have an allergy to iodine
I have an active infection or recent serious illness
I have had a steroid injection in the last three months
I am currently receiving treatment that weakens my immune system
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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Status
Eligibility Criteria
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. Will…
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
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