NCT05543941

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,600

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Apr 2023Dec 2027

First Submitted

Initial submission to the registry

September 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

4 years

First QC Date

September 13, 2022

Last Update Submit

August 8, 2025

Conditions

Hip OsteoarthritisHip ArthritisKnee OsteoarthritisKnee Arthritis

Outcome Measures

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.

    2 weeks after surgery, 3 months after surgery, within 90 day of surgery

Secondary Outcomes (6)

  • Rate of Superficial Wound Infections

    2 weeks after surgery

  • Rate of PJI at 1 year

    12 months after surgery

  • Subgroup analysis of PJI rates for high-risk patients

    3 months after surgery, 12 months after surgery

  • Patient Reported Functional Outcome Scores

    Before surgery, 3 months after surgery, 12 months after surgery

  • Patient Reported Quality of Life Scores

    Before surgery, 3 months after surgery, 12 months after surgery

  • +1 more secondary outcomes

Study Arms (2)

XPERIENCE Advanced Surgical Irrigation

EXPERIMENTAL

Patients will receive the XPERIENCE Advanced Surgical Irrigation prior to wound closure.

Device: XPERIENCE Advanced Surgical Irrigation

Dilute Betadine

ACTIVE COMPARATOR

Patients will receive Dilute Betadine solution prior to wound closure.

Device: Dilute Betadine

Interventions

XPERIENCE Advanced Surgical IrrigationDEVICE

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.

Also known as: XP
XPERIENCE Advanced Surgical Irrigation
Dilute BetadineDEVICE

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.

Also known as: DB, Providone-Iodine
Dilute Betadine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of British Columbia

Vancouver, British Columbia, Canada

NOT YET RECRUITING

London Health Sciences Center

London, Ontario, Canada

RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Humber River Health

Toronto, Ontario, Canada

NOT YET RECRUITING

St. Joseph's Health Centre

Toronto, Ontario, Canada

RECRUITING

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

NOT YET RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

NOT YET RECRUITING

McGill University

Montreal, Quebec, Canada

NOT YET RECRUITING

CHU de Quebec-Université Laval

Québec, Quebec, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Simon Garceau, MD

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjula Costa

CONTACT

613-737-8899scosta@ohri.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

April 1, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

No IPD will be made available to other researchers

Locations

CA(9)