NCT06126614 Infection Prophylaxis in Total Joint Replacement
| NCT ID | NCT06126614 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hamilton Health Sciences Corporation |
| Condition | Periprosthetic Joint Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 21,006 participants |
| Start Date | 2024-05-07 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 21,006 participants in total. It began in 2024-05-07 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 help bring relief to those with osteoarthritis when other treatment options are no longer helpful. Infection is the main reason hip and knee replacements "fail". Failure leads to repeat surgeries that are often more complicated and less likely to be successful than the first surgery. Reducing the risk of infection is extremely important, antiseptic washes and antibiotics may help us do that. After joint replacement surgery, orthopaedic surgeons wash and clean the surgical wound to lower the risk of infection. The goal of this clinical trial is to determine if the use of antiseptic solutions to wash the surgical site and placing an antibiotic directly into the wound will reduce the number of infections requiring reoperation. Patients having total joint replacements will be randomized (like flipping a coin) to receive 6 possible combinations of washes and / or antibiotics. Participants will be followed for one year after TJR to compare the rate of infection in each group.
Eligibility Criteria
Inclusion Criteria: 1. Patients 18 years of age or older. 2. Undergoing primary or aseptic revision TJR. 3. No contraindications to study interventions. 4. Informed consent (participant or substitute decision maker) obtained and willing to comply with the protocol. Exclusion Criteria: 1. Received antibiotics for any reason in the two weeks prior to their TJR. 2. Chronic or acute infection at or near the TJR site. 3. Prior history of periprosthetic joint infection including any reoperation due to infection. 4. Undergoing surgery for a diagnosis of a fracture. 5. Open infected wounds on affected limb. 6. Undergoing bilateral TJR. 7. Currently enrolled in a study that does not permit co-enrollment. 8. Prior enrollment in the trial including the pilot study 9. Any condition or circumstance, which in the opinion of the Investigator, interferes with assessments or completion of the trial.
Contact & Investigator
Thomas J Wood, MD, FRCSC
PRINCIPAL INVESTIGATOR
Hamilton Health Sciences / McMaster University
Frequently Asked Questions
Who can join the NCT06126614 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periprosthetic Joint Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06126614 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 21,006 participants.
Is NCT06126614 currently recruiting?
Yes, NCT06126614 is actively recruiting participants. Contact the research team at maharajli@hhsc.ca for enrollment information.
Where is the NCT06126614 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT06126614 clinical trial?
NCT06126614 is sponsored by Hamilton Health Sciences Corporation. The principal investigator is Thomas J Wood, MD, FRCSC at Hamilton Health Sciences / McMaster University. The trial plans to enroll 21,006 participants.