Hip OsteoarthritisXPERIENCENCT05543941
Evaluating XPERIENCE™ Advanced Surgical Irrigation
A study testing XPERIENCE Advanced Surgical Irrigation and Dilute Betadine in people with Hip Osteoarthritis and Hip Arthritis, run by Ottawa Hospital Research Institute at 8 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Hip Arthritis, Knee Osteoarthritis
- What is being tested?
- XPERIENCE Advanced Surgical Irrigation and Dilute Betadine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,600 participants
- Where
- 8 sitesCanada
- Study dates
- 1 Apr 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Willing and able to sign written consent, follow study protocol and attend follow-up
Who cannot join
- 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.)
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- 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 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.
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Canada8 sites, 8 recruiting
- Recruiting
London Health Sciences Center
London, Ontario
Abbigail Allen, 519-685-8500 ext. 37843, Abbigail.Allen@lhsc.on.ca
Brent Lanting, MD
- Recruiting
Hôpital Maisonneuve-Rosemont
Montreal, Quebec
Serge Marquis, 514-252-3400 ext. 5701, smarquis.hmr@ssss.gouv.qc.ca
Janie Barry, jbarry.hmr@ssss.gouv.qc.ca
- Recruiting
Jewish General Hospital
Montreal, Quebec
Laura Epure, laura.epure@mcgill.ca
John Antoniou, MD
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Sanjula Costa, 613-737-8899 ext. 72640, scosta@ohri.ca
Simon Garceau, MD
- Recruiting
CHU de Quebec-Université Laval
Québec, Quebec
Sylvie Turmel, 418-525-4444 ext. 66175, turmel.sylvie@chudequebec.ca
Etienne Belzile, MD
- Recruiting
Humber River Health
Toronto, Ontario
Michele Petrovic, 416-242-1000 ext. 81263, MPetrovic@hrh.ca
Sebastian Rodriguez-Elizalde, MD
- Recruiting
St. Joseph's Health Centre
Toronto, Ontario
Carlos Fernando, 416-864-6060 x 46969, Carlos.Fernando@unityhealth.to
George Vincent, MD
- Recruiting
University of British Columbia
Vancouver, British Columbia
Kelsey Lee, kelsey.lee@vch.ca
Michael Neufeld, MD
About this study
Official title: Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled 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).
- Conditions
- Hip Osteoarthritis, Hip Arthritis, Knee Osteoarthritis, Knee Arthritis
- Being tested
- XPERIENCE Advanced Surgical Irrigation, Dilute Betadine
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XPERIENCE Advanced Surgical IrrigationDevice
Also called XP
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 BetadineDevice
Also called DB, Providone-Iodine
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.
| Study group | Role | What they receive |
|---|---|---|
| XPERIENCE Advanced Surgical Irrigation | Experimental | Patients will receive the XPERIENCE Advanced Surgical Irrigation prior to wound closure. Receives: Device: XPERIENCE Advanced Surgical Irrigation |
| Dilute Betadine | Active comparator | Patients will receive Dilute Betadine solution prior to wound closure. Receives: Device: Dilute Betadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of acute (<90 days post-surgery) PJI
Number of patients diagnosed with periprosthetic joint infection as per the diagnostic criteria outlined by the 2018 International Consensus Meeting of the Musculoskeletal Infection Society for Acute PJI.
Measured: 2 weeks after surgery, 3 months after surgery, within 90 day of surgery
Secondary outcomes (6)
Rate of Superficial Wound Infections
Number of superficial wound infections
Measured: 2 weeks after surgery
Rate of PJI at 1 year
Number of patients diagnosed with periprosthetic joint infections at 1 year after surgery
Measured: 12 months after surgery
Subgroup analysis of PJI rates for high-risk patients
Number of patients diagnosed with PJI at 3 months and 1 year in higher risk patient categories (morbid obesity (BMI >40kg/m2), diabetes mellitus, chronic kidney disease, inflammatory arthritis, active smokers (nicotine))
Measured: 3 months after surgery, 12 months after surgery
Patient Reported Functional Outcome Scores
As measured by the Oxford Hip Score (OHS) or Oxford Knee Score (OKS)
Measured: Before surgery, 3 months after surgery, 12 months after surgery
Patient Reported Quality of Life Scores
As measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Measured: Before surgery, 3 months after surgery, 12 months after surgery
Wound Complications (non-infection) requiring revision surgery
Number of patients requiring a revision surgery for a non-infection related wound complication
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Apr 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- OsteoRemedies, LLC
- Responsible party
- Sponsor
- Investigators
- Simon Garceau, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543941
- Sponsor's protocol ID
- ISR-0104
- Acronym
- XPERIENCE
- Status last verified
- May 2026
- First submitted
- 13 Sep 2022
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD will be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05543941
- Acronym / sponsor ID
- XPERIENCE / ISR-0104
- Conditions
- Hip Osteoarthritis, Hip Arthritis, Knee Osteoarthritis, Knee Arthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7,600 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- OsteoRemedies, LLC
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XPERIENCE Advanced Surgical Irrigation | Experimental | Device: XPERIENCE Advanced Surgical IrrigationPatients will receive the XPERIENCE Advanced Surgical Irrigation prior to wound closure. |
| Dilute Betadine | Active comparator | Device: Dilute BetadinePatients will receive Dilute Betadine solution prior to wound closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Willing and able to sign written consent, follow study protocol and attend follow-up
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XPERIENCE Advanced Surgical IrrigationAlso: XPThe 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. | Device | XPERIENCE Advanced Surgical Irrigation |
| Dilute BetadineAlso: DB, Providone-IodineThe 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. | Device | Dilute Betadine |
Primary outcome
Rate of acute (<90 days post-surgery) PJI
Time frame: 2 weeks after surgery, 3 months after surgery, within 90 day of surgery
Number of patients diagnosed with periprosthetic joint infection as per the diagnostic criteria outlined by the 2018 International Consensus Meeting of the Musculoskeletal Infection Society for Acute PJI.
6 secondary outcomes
Rate of Superficial Wound Infections
Time frame: 2 weeks after surgery
Rate of PJI at 1 year
Time frame: 12 months after surgery
Subgroup analysis of PJI rates for high-risk patients
Time frame: 3 months after surgery, 12 months after surgery
Patient Reported Functional Outcome Scores
Time frame: Before surgery, 3 months after surgery, 12 months after surgery
Patient Reported Quality of Life Scores
Time frame: Before surgery, 3 months after surgery, 12 months after surgery
Wound Complications (non-infection) requiring revision surgery
Time frame: 2 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No. No IPD will be made available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simon Garceau, MD principal investigator
The Ottawa Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XPERIENCE Advanced Surgical Irrigation and Dilute Betadine in people with Hip Osteoarthritis and Hip Arthritis, run by Ottawa Hospital Research Institute at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanjula Costa (613-737-8899 ext. 72640, scosta@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.