Evaluating XPERIENCE™ Advanced Surgical Irrigation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
XPERIENCE Advanced Surgical Irrigation
DeviceThe 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 Betadine
DeviceThe 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.
Treatment groups
7,600 Participants
are divided into 2 treatment groupsGroup A: XPERIENCE Advanced Surgical IrrigationExperimental treatment 1 intervention
Group B: Dilute BetadineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 weeks after surgery, 3 months after surgery, within 90 day of surgerySecondary outcomes
1
Rate of Superficial Wound Infections
Number of superficial wound infections
Time frame
2 weeks after surgery2
Rate of PJI at 1 year
Number of patients diagnosed with periprosthetic joint infections at 1 year after surgery
Time frame
12 months after surgery3
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))
Time frame
3 months after surgery, 12 months after surgery4
Patient Reported Functional Outcome Scores
As measured by the Oxford Hip Score (OHS) or Oxford Knee Score (OKS)
Time frame
Before surgery, 3 months after surgery, 12 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Ottawa Hospital Research Institute
Lead sponsor
OsteoRemedies, LLC
Collaborator
Source ClinicalTrials.gov