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Early vs Delayed Weightbearing After Ankle Fracture Surgery
N/A
Recruiting
Research Sponsored by University of Arizona
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 enrollment through 1 year
Awards & highlights
Study Summary
This trial will compare early weightbearing after ankle surgery to traditional non-weightbearing to see if it improves outcomes and speeds return to work. Excludes severe ankle injuries and comorbidities.
Who is the study for?
This trial is for adults who've had surgery to fix an unstable ankle fracture with syndesmosis disruption within two weeks of injury. They must be able to bear weight on the affected leg and not have severe open fractures, other major injuries, a very high BMI, previous ankle surgeries on the same side, or conditions that prevent following post-op instructions.Check my eligibility
What is being tested?
The study compares early versus delayed weightbearing after surgical fixation of unstable ankle fractures. It aims to see if starting to put weight on the foot soon after surgery leads to better function, faster return to work, and how it affects complication rates.See study design
What are the potential side effects?
Potential side effects may include increased pain during early movement, risk of re-injury or complications related to putting weight on the operated ankle too soon compared with waiting longer before bearing weight.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment through 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment through 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Loss of reduction of the syndesmosis
Olerud Molander
Physical Exam Functional Outcomes
+3 moreSecondary outcome measures
Difference in rates of Adverse Events
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Early weightbearing (as tolerated) GroupExperimental Treatment1 Intervention
At 0 weeks to 2 weeks post operation, subjects will be provided CAM (controlled ankle motion walking) boot and instructed to be non-weightbearing on the ankle, using crutches for assistance. During 2nd week, subject will visit clinic where staples/stitches will be removed, with instructions to be weightbearing as tolerated. Instructions for limited range of motion to be given, passive/active range of motion out of boot will be allowed. Between 2 to 6 weeks, subject will continue with weightbearing as tolerated in orthosis, following range of motion instructions. After 6 weeks, the subject will continue with weightbearing as tolerated, and be weaned from orthosis.
At each follow-up visit, as part of the subject's standard of care, a physical examination and radiographic assessments will be completed, and that data collected for research purposes. Subject will also be requested to complete outcome questionnaires during their participation.
Group II: Non-weightbearing GroupActive Control1 Intervention
At 0 weeks to 2 weeks post operation, subjects will be provided CAM (controlled ankle motion walking) boot and instructed to be non-weightbearing on the ankle, using crutches for assistance. During 2nd week, subject will visit clinic where staples/stitches will be removed, with instructions to continue non-weightbearing w/ crutches. Instructions for limited range of motion to be given, passive/active range of motion out of boot will be allowed. Between 2 to 6 weeks, the subject will continue with non-weightbearing and follow range of motion instructions. After 6 weeks, the subject will begin weightbearing as tolerated. Instructions for limited range of motion to be given, and be weaned from orthosis.
At each follow-up visit, as part of the subject's standard of care, a physical examination and radiographic assessments will be completed, and that data collected for research purposes. Subject will also be requested to complete outcome questionnaires during their participation.
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Who is running the clinical trial?
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,444 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery on the same ankle before.I do not have numbness, tingling, or pain in my hands or feet.I have a fracture in the lower part of my shinbone affecting the joint.My BMI is over 45.I have a severe ankle injury involving the syndesmosis ligament.I had surgery on my ankle or the connecting tissue within two weeks of getting hurt.I have fractures in both ankles or other serious leg injuries.I was unable to walk before my injury.I am able to follow post-op instructions and do not have conditions like advanced dementia.My fracture is either closed or a minor open wound without serious contamination.My bones have finished growing.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Non-weightbearing Group
- Group 2: Early weightbearing (as tolerated) Group
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 participants are currently partaking in this experiment?
"Affirmative. Clinicaltrials.gov elucidates that this medical experiment, first made available on February 10th 2021, is currently recruiting participants. 150 patients across 1 site are needed to complete the trial."
Answered by AI
Is enrollment in this trial still available to those seeking treatment?
"This ongoing clinical trial, which was first made public on February 10th 2021, is still in need of willing participants. The details have been recently modified as recent as October 17th 2022 according to the information provided by clinicaltrials.gov"
Answered by AI
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