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Amobarbital/Gel-One for Osteoarthritis
Study Summary
This trial is testing whether amobarbital can prevent post-traumatic osteoarthritis in people who have fractured their ankle joints. The study is double-blind, meaning that neither the patients nor the researchers will know who is receiving the placebo or the active treatment. The study team will assess safety and begin to evaluate efficacy of amobarbital/Gel-One in patients having sustained tibial pilon fractures. The study team will use advanced imaging-based methods we have developed to characterize how joints subjected to varying levels of fracture severity and residual elevated contact stress respond in treated and control groups.
- Osteoarthritis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have a broken bone on the same side as the treatment.You have a pre-existing condition that affects your immune system or blood cells.You have arthritis in your ankle before starting the study.If you have a broken bone, it must be treated within 72 hours of injury with an injection of amobarbital or a placebo.You have injuries that prevent you from undergoing normal rehabilitation.You have a pre-existing condition that affects your kidneys, liver, blood, immune system or endocrine system (excluding diabetes).You have a certain type of ankle fracture that involves a break in the bone near the back of the ankle joint and affects a large part of the joint surface.You have had an injury to your ankle in the past.You are allergic to chicken or cinnamon.You have severe, open wounds.You have diabetes.You have a certain type of ankle fracture that is not severe enough to require surgery.
- Group 1: Phase I single amobarbital/Gel-One dose
- Group 2: Phase IIa Part 1 Placebo
- Group 3: Phase IIa Part 2 amobarbital/Gel-One dose
- Group 4: Phase IIa Part 2 placebo
- Group 5: Phase IIa Part 1 amobarbital/Gel-One dose
- 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
Are there similar cases to this amobarbital/Gel-One study?
"One clinical trial is ongoing for amobarbital/Gel-One (one dose), which is in Phase 3, with 1 location in Iowa City, Iowa."
How many study participants can join this trial at most?
"The most recent information available on clinicaltrials.gov says that this study, which was posted on 7/20/2022, is still actively enrolling patients. 66 patients are needed at 1 site."
What outcomes does this experiment hope to produce?
"The goal of this study is to determine the number of participants with a change in local toxicity in tissues. Secondary objectives include CT-based contact stress and the American Orthopaedic Foot and Ankle Society (AOFAS) score. The study will be measured over a period of Pre-op baseline on the day before external fixation surgery (within 24 hours of injury), immediately post-op, and at 1, 2, and 4 days post-op."
If an octogenarian meets the other requirements, can they participate in this research project?
"The ideal patient for this clinical trial is someone who is over 18 but younger than 60 years old."
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