Evaluating XPERIENCE™ Advanced Surgical Irrigation

Not Applicable

Recruiting

• Conditions: Knee Arthritis; Knee Osteoarthritis; Hip Arthritis; Hip Osteoarthritis
• Interventions: Device: XPERIENCE Advanced Surgical Irrigation; Device: Dilute Betadine

• Registration Number: NCT05543941
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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 Irrigation versus dilute Betadine (DB).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-16
• Study Start: 2023-04-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2027-03-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7600

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
XPERIENCE Advanced Surgical Irrigation	XPERIENCE Advanced Surgical Irrigation	Patients will receive the XPERIENCE Advanced Surgical Irrigation prior to wound closure.
Dilute Betadine	Dilute Betadine	Patients will receive Dilute Betadine solution prior to wound closure.

Primary Outcome Measures

Name	Time	Method
Rate of acute (<90 days post-surgery) PJI	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.

Secondary Outcome Measures

Name	Time	Method
Patient Reported Quality of Life Scores	Before surgery, 3 months after surgery, 12 months after surgery	As measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Subgroup analysis of PJI rates for high-risk patients	3 months after surgery, 12 months after surgery	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))
Rate of PJI at 1 year	12 months after surgery	Number of patients diagnosed with periprosthetic joint infections at 1 year after surgery
Patient Reported Functional Outcome Scores	Before surgery, 3 months after surgery, 12 months after surgery	As measured by the Oxford Hip Score (OHS) or Oxford Knee Score (OKS)
Rate of Superficial Wound Infections	2 weeks after surgery	Number of superficial wound infections
Wound Complications (non-infection) requiring revision surgery	2 weeks after surgery	Number of patients requiring a revision surgery for a non-infection related wound complication

Trial Locations

Locations (9)

St. Joseph's Health Centre; 🇨🇦 Toronto, Ontario, Canada

Humber River Health; 🇨🇦 Toronto, Ontario, Canada

London Health Sciences Center; 🇨🇦 London, Ontario, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

CHU de Quebec-Université Laval; 🇨🇦 Québec, Quebec, Canada

Hôpital Maisonneuve-Rosemont; 🇨🇦 Montréal, Quebec, Canada

Jewish General Hospital; 🇨🇦 Montréal, Quebec, Canada

McGill University; 🇨🇦 Montréal, Quebec, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada