Hip Osteoarthritis study: Dilute Betadine
Official title Evaluating XPERIENCE™ Advanced Surgical Irrigation
ClinicalTrials.gov ID: NCT05543941
What this study is testing
- What it's testing
- The study wants to find out whether using XPERIENCE™ during knee or hip surgery lowers the chance of infection around the joint implant compared to the usual Betadine solution.
- Who it's for
- Adults who are scheduled for a new knee replacement, hip replacement, or hip resurfacing surgery.
- What's involved
- Participants will receive either the XPERIENCE™ irrigation or a diluted Betadine solution during their operation. After surgery, they will have routine follow‑up visits and tests to check for infection.
- Time commitment
- The study lasts from the day of surgery through the follow‑up period, which includes several post‑operative visits over the next months.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- people receiving both cemented or uncemented orthopaedic implants
- Willing and able to sign written consent, follow study protocol and attend follow-up
You likely can't join if
- 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.)
See the full eligibility criteria
- 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
- people receiving both cemented or uncemented orthopaedic implants
- Willing and able to sign written consent, follow study protocol and attend follow-up
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Vancouver, British Columbia, Canada
- London, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Vancouver, British Columbia, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Québec, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.