Status:
RECRUITING
Infection Prophylaxis in Total Joint Replacement
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
McMaster University
Ontario Clinical Oncology Group (OCOG)
Conditions:
Periprosthetic Joint Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Osteoarthritis (OA) is the most common cause of disability in older adults worldwide affecting 7% of the global population, or more than 500 million people globally. Total joint replacements (TJR) can...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older.
- Undergoing primary or aseptic revision TJR.
- No contraindications to study interventions.
- Informed consent (participant or substitute decision maker) obtained and willing to comply with the protocol.
Exclusion
- Received antibiotics for any reason in the two weeks prior to their TJR.
- Chronic or acute infection at or near the TJR site.
- Prior history of periprosthetic joint infection including any reoperation due to infection.
- Undergoing surgery for a diagnosis of a fracture.
- Open infected wounds on affected limb.
- Undergoing bilateral TJR.
- Currently enrolled in a study that does not permit co-enrollment.
- Prior enrollment in the trial including the pilot study
- Any condition or circumstance, which in the opinion of the Investigator, interferes with assessments or completion of the trial.
Key Trial Info
Start Date :
May 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
21006 Patients enrolled
Trial Details
Trial ID
NCT06126614
Start Date
May 7 2024
End Date
November 1 2028
Last Update
September 19 2024
Active Locations (1)
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1
Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada, L8V 1C3