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Early vs Delayed Weight-Bearing for Ankle Injury
N/A
Waitlist Available
Led By Kyle Schweser, MD
Research Sponsored by Kyle Schweser MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ankle fracture with suspected syndesmotic disruption that would likely be treated with suture button fixation operative intervention
Ability to ambulate preoperatively
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks to 1 year
Awards & highlights
Study Summary
This trialis studying immediate weight bearing after ankle surgery with syndesmotic suture button fixation, to see if it's safe and effective and to compare it to delayed weight bearing.
Who is the study for?
Adults over 18 who can walk on their own and have an ankle fracture with a suspected syndesmotic injury, likely needing suture button surgery. Not for pregnant or breastfeeding individuals, those under 18, weighing over 325 pounds, prisoners, people unable to follow commands due to conditions like dementia or TBI, patients with end-stage renal disease, severe syndesmotic injuries (Maisonneuve), or neuropathic diabetics.Check my eligibility
What is being tested?
The study is testing if patients with ankle fractures involving the syndesmosis can safely put weight on their foot early (2 weeks after surgery) versus late (6 weeks). They're randomly assigned to one of these two groups. The main goal is seeing if the position of the bones stays correct after a year using CT scans.See study design
What are the potential side effects?
Potential side effects may include pain at the injury site, complications from wound healing such as infection, hardware failure like broken screws or buttons used in fixation procedures and issues related to not being able to use the injured leg normally.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a broken ankle that may need surgery with a special suture technique.
Select...
I can walk on my own before surgery.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure of the syndesmotic change
Secondary outcome measures
Foot and ankle outcomes (AAOS)
Pain scores
Surgical Experience (SSQ-8)
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Early Weight-BearingActive Control1 Intervention
Being directed to bear weight on the affected ankle two weeks from suture button fixation for syndesmotic disruption
Group II: Delayed/Late Weight-BearingActive Control1 Intervention
Being directed to bear weight on the affected ankle six weeks from suture button fixation for syndesmotic disruption
Find a Location
Who is running the clinical trial?
Kyle Schweser MDLead Sponsor
2 Previous Clinical Trials
75 Total Patients Enrolled
Kyle Schweser, MDPrincipal Investigator - University of Missouri Health System, Department of Orthopaedic Surgery
University of Missouri-Columbia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently pregnant or breastfeeding.I have a broken ankle that may need surgery with a special suture technique.I can walk on my own before surgery.I am 18 years old or older.I have a specific type of ankle injury.I have nerve damage due to diabetes.My kidneys are in the final stage of failure.I cannot follow commands due to a condition like dementia.You have multiple injuries from a traumatic event.I am under 18 years old.I weigh 325 pounds or more.
Research Study Groups:
This trial has the following groups:- Group 1: Early Weight-Bearing
- Group 2: Delayed/Late Weight-Bearing
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.
What is the magnitude of participants in this trial?
"Affirmative. As indicated on clinicaltrials.gov, this pharmaceutical trial is actively enrolling 40 test subjects at a single location. The study was initially posted on October 15th 2019 and most recently updated November 2nd 2022."
Answered by AI
Does this trial remain available to potential participants?
"Affirmative. Clinicaltrials.gov data displays that recruitment for this trial is ongoing; it was initially posted on October 15th 2019, and more recently updated on November 2nd 2022. 40 patients are needed from a single medical facility."
Answered by AI
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