Evaluating XPERIENCE™ Advanced Surgical Irrigation

Knee Osteoarthritis Clinical Trial

— XPERIENCE  

Official title:

Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05543941
• Other study ID #: ISR-0104
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2024
• Source: Ottawa Hospital Research Institute
• Contact: Sophie Henke Tarnow
• Phone: 613-737-8899
• Email: shenke[@]ohri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Irrigation versus dilute Betadine (DB).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7600
• Est. completion date: December 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Hip Arthritis
• Hip Osteoarthritis
• Knee Arthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• XPERIENCE Advanced Surgical Irrigation
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 Betadine
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.

Locations

Country	Name	City	State
Canada	London Health Sciences Center	London	Ontario
Canada	Hôpital Maisonneuve-Rosemont	Montréal	Quebec
Canada	Jewish General Hospital	Montréal	Quebec
Canada	McGill University	Montréal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	CHU de Quebec-Université Laval	Québec	Quebec
Canada	Humber River Health	Toronto	Ontario
Canada	St. Joseph's Health Centre	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Next Science TM

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks after surgery, 3 months after surgery, within 90 day of surgery
Secondary	Rate of Superficial Wound Infections	Number of superficial wound infections	2 weeks after surgery
Secondary	Rate of PJI at 1 year	Number of patients diagnosed with periprosthetic joint infections at 1 year after surgery	12 months after surgery
Secondary	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))	3 months after surgery, 12 months after surgery
Secondary	Patient Reported Functional Outcome Scores	As measured by the Oxford Hip Score (OHS) or Oxford Knee Score (OKS)	Before surgery, 3 months after surgery, 12 months after surgery
Secondary	Patient Reported Quality of Life Scores	As measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)	Before surgery, 3 months after surgery, 12 months after surgery
Secondary	Wound Complications (non-infection) requiring revision surgery	Number of patients requiring a revision surgery for a non-infection related wound complication	2 weeks after surgery