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Antibiotic
Tourniquet Use for Prosthetic Joint Infections
N/A
Recruiting
Led By Adam Hart, MD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years for study completion
Awards & highlights
Study Summary
This trial examines the effects of tourniquet use during knee surgery on antibiotic distribution and tissue concentrations.
Who is the study for?
Adults aged 18-85 needing a primary total knee replacement due to conditions like osteoarthritis, rheumatoid arthritis, or avascular necrosis can join. Those with MRSA colonization, severe allergies to the study antibiotic, or severe kidney issues (eGFR < 30 ml/min) cannot participate.Check my eligibility
What is being tested?
The trial is testing how using a tourniquet during knee surgery affects the concentration of Ancef (an antibiotic) in tissue around the incision. It's looking at whether less blood flow from the tourniquet means less antibiotic gets to where it's needed.See study design
What are the potential side effects?
Potential side effects may include reduced distribution of antibiotics to affected tissues which could impact infection prevention. The use of a tourniquet might also cause discomfort or circulation issues in the leg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two years for study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years for study completion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adipose tissue
Trial Design
2Treatment groups
Active Control
Group I: TourniquetActive Control1 Intervention
25 participants with tourniquet application
Group II: No tourniquetActive Control1 Intervention
25 participants without tourniquet application
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Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
449 Previous Clinical Trials
159,796 Total Patients Enrolled
Adam Hart, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
1 Previous Clinical Trials
200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My gender does not limit my participation.I have been diagnosed with osteoarthritis, rheumatoid arthritis, or avascular necrosis.My kidney function is severely reduced.I need surgery to fix a previous operation.I am between 18 and 85 years old and need a knee replacement.
Research Study Groups:
This trial has the following groups:- Group 1: Tourniquet
- Group 2: No tourniquet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been enrolled in this trial thus far?
"Affirmative. According to the data located on clinicaltrials.gov, enrollment in this trial is open and ongoing; it was initially posted on September 16th 2021 and most recently edited November 2nd 2022. The medical research requires 50 participants from a single site."
Answered by AI
Do my qualifications meet the criteria for this research study?
"This clinical trial seeks to enroll 50 individuals that are between 18 and 85 years of age, who have prosthetic joint infections."
Answered by AI
Are individuals over the age of 55 eligible to participate in this investigation?
"This research is open to persons aged 18 and above, up until 85 years old."
Answered by AI
Are recruits still being sought for this research project?
"According to the clinicaltrials.gov database, enlistment is currently open for this medical study that was initially posted on September 16th 2021 and subsequently updated in November 2nd 2022."
Answered by AI
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