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Cephalosporin Antibiotic
Ceftriaxone for Meniscus Tears (PROPER Trial)
Phase 2
Waitlist Available
Led By Austin V Stone, MD, PhD
Research Sponsored by Austin V Stone
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operative, 2 months post-operative
Awards & highlights
Summary
This trial is testing if an antibiotic called ceftriaxone can reduce pain and the need for strong painkillers in patients with cartilage or meniscal injuries. Ceftriaxone works by lowering inflammation, which helps to reduce pain. Ceftriaxone has been shown to be effective in reducing pain and inflammation in various types of surgeries.
Eligible Conditions
- Meniscus Tears
- Meniscal Injury
- Cartilage Injury
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-operative, 2 months post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-operative, 2 months post-operative
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in RU SATED Score
Change in Visual Analog Scale (VAS) Pain Score
Post-operative Narcotic Use
Side effects data
From 2021 Phase 4 trial • 32 Patients • NCT0421869512%
Decompensated cirrhosis
6%
Hepatic Failure
6%
Rectus sheath hematoma
6%
Nausea
6%
Pruritus with rash
6%
Possible gastrointestinal bleed
6%
hyperkalemia
6%
UTI
6%
Hepatic Encephalopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
The experimental group will receive a single intravenous dose of 1 g of ceftriaxone immediately postoperative in the operating room.
Group II: PlaceboPlacebo Group1 Intervention
The placebo group will receive a single intravenous dose of 1% lidocaine and saline immediately postoperative in the operating room.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceftriaxone
2019
Completed Phase 4
~9340
Find a Location
Who is running the clinical trial?
Austin V StoneLead Sponsor
4 Previous Clinical Trials
69 Total Patients Enrolled
2 Trials studying Meniscus Tears
68 Patients Enrolled for Meniscus Tears
Austin V Stone, MD, PhDPrincipal InvestigatorUniversity of Kentucky
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had allergic reactions to cephalosporins before.You have signs of an infection or crystal disease in your knee within the past month.You have received any treatment directly into a joint within the past six months, such as corticosteroids or biologic agents like platelet rich plasma (PRP) or stem cells.You have received a treatment called hyaluronic acid in your knee, either as a research study or a regular treatment, within the last 6 months before screening.You have taken any corticosteroid medications (injections or pills) within the past 3 months before the screening.You need to have knee arthroscopy for a procedure on your cartilage or meniscus.You have certain types of arthritis or joint inflammation related to other health conditions.You had an infection in your knee in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
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