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Early Weight Bearing for Ankle Fracture
Study Summary
This trial is testing whether it's better to wait or start bearing weight immediately after surgery for an ankle fracture.
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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Who is running the clinical trial?
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- I had surgery for a specific type of broken ankle or lower leg bone.I have severe burns on more than 10% of my body, including the limb being studied.I have injuries that prevent me from putting weight on my arms or legs.I have nerve damage or a broken bone due to cancer.I have osteoporosis, confirmed by medication use or a past weak-bone fracture.I have had surgery to fix an injury in my ankle joint.I have a severe injury to my leg that prevents me from putting weight on it.I am 18 years old or older.I have a specific type of knee fracture and may have mobility or health issues that could affect my treatment.
- Group 1: Delayed Weight Bearing
- Group 2: Early Weight Bearing
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 vacancies in this research study that participants can fill?
"As per the details on clinicaltrials.gov, this research is currently enrolling participants. The trial's initial posting date was January 1st 2020 and its last update occurred October 12th 2022."
Do elderly individuals aged 85 and over qualify for this experiment?
"This research study seeks participants aged 18 or over, but under 65."
What must I do to become eligible for this experiment?
"This clinical trial is recruiting 450 individuals over 18 and under 65 who require rehabilitation. Prerequisites for candidates include: being of legal age, having a bimalleolar fracture necessitating fixation on two malleoli (e.g., lateral/medial, medial/posterior or lateral/posterior), possessing an analogous SER4 injury (lateral malleolus break needing to be fixed without the need for either medial or posterior malleolus fixation), trimalleolar fracture with at least two malleoli requiring fixing (i.e., lateral/medial, medial/posterior or lateral/"
How many sites are currently hosting this clinical trial?
"There are 20 trial locations currently participating, such as Walter Reed National Military Medical Center in Bethesda, University of California San Francisco Medical Center in San Francisco, and Vanderbilt University Medical Center in Nashville. There are also 17 other medical centres providing this clinical service."
What is the topmost number of individuals participating in this clinical investigation?
"Affirmative, the clinicaltrial.gov portal reveals that this research is actively recruiting patients. Initially posted on January 1st 2020 and recently updated as of October 12th 2022, it seeks to enroll a total of 450 individuals from 20 different sites."
For what purpose is this investigation striving to attain?
"The main focus of this 12-month trial is ascertaining the Return to Usual Major Activity and Work Productivity rate. Secondary objectives are gauging Joint Range of Motion, Self-Reported Measures of Function, and Pain Score with evidence like a plastic goniometer for physical examination, PROMIS CAT item banks as well as BPI pain intensity domain compliant with FDA standards."
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