← Back to Search

Early Weight Bearing for Ankle Fracture

N/A
Recruiting
Led By Lisa Reider, PhD
Research Sponsored by Major Extremity Trauma Research Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Surgically treated open or closed fractures of the ankle meeting specific criteria: bimalleolar fracture requiring fixation of any two malleoli, bimalleolar equivalent SER4 fractures, trimalleolar fracture with fixation of at least two malleoli, operative treatment of an isolated lower extremity unicondylar tibial plateau fracture without joint impaction
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing whether it's better to wait or start bearing weight immediately after surgery for an ankle fracture.

Who is the study for?
Adults over 18 with certain types of ankle or tibial plateau fractures that have been surgically treated can join this trial. Excluded are those with severe soft tissue injuries, syndesmotic injuries, upper limb weight-bearing limitations, morbid obesity (BMI ≥40), psychiatric disorders affecting compliance, and other conditions like neuropathy or osteoporosis.Check my eligibility
What is being tested?
The study is examining the effects of allowing patients to put weight on their leg early after surgery for an ankle fracture without syndesmotic fixation or a specific type of tibial plateau fracture. It compares early versus delayed weight bearing in terms of rehabilitation outcomes.See study design
What are the potential side effects?
Since the intervention involves early weight bearing rather than medication, side effects may include pain at the injury site, potential stress to healing bones or joints, and risk of re-injury if the bone has not healed sufficiently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had surgery for a specific type of broken ankle or lower leg bone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Study Related Complications Experienced
Return to Usual Major Activity and Work Productivity
Secondary outcome measures
Joint Range of Motion (ROM)
Pain Interference
Pain Score
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early Weight BearingExperimental Treatment1 Intervention
Patients with ankle fractures will be instructed to weight bear as tolerated (WBAT) while in a boot with a heel to toe normal gait and wean from walker or crutches to a cane or no support device. At the 6 week post op visit, patients with ankle fractures will be instructed to wean from the boot and continue full weight bearing as tolerated until full weight bearing is achieved. Patients with plateau fractures will be instructed to begin WBAT until full weight bearing is achieved.
Group II: Delayed Weight BearingActive Control1 Intervention
Patients with ankle fractures will be instructed to touch-down (toe touch or foot flat) weight bear (approximately 10% of body weight) while in the boot for. Patients will be instructed to keep foot off of floor or set ball of foot or heal on ground for balance using walker or crutches at all times. After the 6 week post op visit, patients may begin weight bearing as tolerated. Patients with tibial plateau fractures will be instructed to touch down (toe touch or foot flat) weight bear (approximately 10% of body weight) for at least 6 weeks. After the 6 week post op visit, patients may begin weight bearing as tolerated until full weight bearing is achieved.

Find a Location

Who is running the clinical trial?

Major Extremity Trauma Research ConsortiumLead Sponsor
30 Previous Clinical Trials
26,576 Total Patients Enrolled
Lisa Reider, PhDPrincipal InvestigatorMajor Extremity Trauma Research Consortium
4 Previous Clinical Trials
983 Total Patients Enrolled

Media Library

Early Weight Bearing Clinical Trial Eligibility Overview. Trial Name: NCT04028414 — N/A
Rehabilitation Research Study Groups: Delayed Weight Bearing, Early Weight Bearing
Rehabilitation Clinical Trial 2023: Early Weight Bearing Highlights & Side Effects. Trial Name: NCT04028414 — N/A
Early Weight Bearing 2023 Treatment Timeline for Medical Study. Trial Name: NCT04028414 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

Do elderly individuals aged 85 and over qualify for this experiment?

"This research study seeks participants aged 18 or over, but under 65."

Answered by AI

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/"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~40 spots leftby Sep 2024