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Recruiting NCT05543941

Evaluating XPERIENCE™ Advanced Surgical Irrigation

No phase Interventional Hip Osteoarthritis Hip Arthritis Knee Osteoarthritis Knee Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: XPERIENCE Advanced Surgical Irrigation, Dilute Betadine.
Who it may be relevant to
Registry conditions: Hip Osteoarthritis, Hip Arthritis, Knee Osteoarthritis, Knee Arthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • 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.
  • Device 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 n

Primary outcome measures

  • Rate of acute (<90 days post-surgery) PJI [Time frame: 2 weeks after surgery, 3 months after surgery, within 90 day of surgery]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion 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
  • Subjects receiving both cemented or uncemented orthopaedic implants
  • Willing and able to sign written consent, follow study protocol and attend follow-up

Exclusion criteria

  • 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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 8 centers
  • University of British Columbia — Vancouver
  • London Health Sciences Center — London
  • The Ottawa Hospital — Ottawa
  • Humber River Health — Toronto
  • St. Joseph's Health Centre — Toronto
  • Hôpital Maisonneuve-Rosemont — Montreal
  • Jewish General Hospital — Montreal
  • CHU de Quebec-Université Laval — Québec

Identifiers

NCT: NCT05543941 · ISR-0104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗