Even-Up to Minimize Secondary Site Pain For Ankle Fracture

Study Overview
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Brief Summary
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Evaluating impact of use of Even-Up shoe wear device for patients treated in CAM boot walker for an ankle fracture. Randomized controlled trial, randomizing patients into control group with boot treatment only versus boot treatment with Even-Up device on contralateral extremity.

Detailed Description
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A variety of foot and ankle injuries can be treated effectively through the use of a controlled ankle movement (CAM) walker boot. CAM walker boots protect the injured area by restricting foot and ankle motion, providing a stable platform to distribute forces while bearing weight, and allowing the user to rollover the foot during ambulation because of a rocker bottom-shaped sole. Such qualities lend the CAM walker boot to provide ankle support that can be advantageous compared with other commonly used methods. Despite their utility, CAM walker boots create a simulated leg-length discrepancy (LLD), which can result in altered biomechanics during ambulation. Additionally, a LLD can be associated with lower back and joint pain. We have previously conducted a study that suggests a relationship exists between CAM walker boot treatment and pain at sites other than the extremity being treated. There have been several randomized controlled trials (RCTs) examining a relationship between the correction of inherent LLD with insole inserts and lower back pain. Furthermore, there has been a past RCT and there is a current RCT examining a relationship between the use of the EVENup orthotic shoe lift to correct CAM walker boot simulated LLD and pain at sites other than the extremity being treated. However, these studies were not conducted with patient populations with uniform injuries. To the best of our knowledge, an RCT has not been conducted with the EVENup orthotic shoe lift to examine this relationship in a uniform patient population with nonoperative ankle fractures. This RCT aims to assess the efficacy of the EVENup orthotic shoe lift, towards reducing and even preventing such pain that may be associated with this common course of treatment.

Official Title
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A Randomized Controlled Trial of Non-Operative Ankle Fractures: Even-Up Orthotic Shoe Lift and CAM Walking Boot Wear

Conditions
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Arthralgia, Trouble Balancing

Intervention / Treatment
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* Device: Even-Up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-operative Treatment of Ankle Fracture CAM boot as treatment for injury Weight bearing ad lib Exclusion Criteria: Pregnancy Non-English speaking Recent surgery for lower extremity or back Recent other injury to lower extremity or back Restricted weight bearing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard CAM boot treatment without Even-Up device. | |
| Experimental: Study<br>CAM boot treatment with Even-Up for contralateral extremity. | Device: Even-Up<br>* Orthotic shoe lift worn on contralateral foot to increase leg length<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Pain (VAS) | Visual Analog Scale (0 - 100) to assess pain at various musculoskeletal sites. Patients are presented with a slider on a scale to indicate the degree to which they are experiencing pain on a scale from No Pain at the far left to Worst Pain at the far right. The position on the scale is then translated into a number from 0 (no pain) to 100 (worst pain). | 0-24 weeks | 
| Patient Reported Outcome (FAAM-ADL, 0 - 100) | FAAM-ADL (Foot and Ankle Ability Measure - Activities of Daily Living, [0 -100]).The FAAM-ADL consists of 21 questions, with a maximum score of 4 per question. The sum of the scores of answered questions is divided by the highest potential score (84 if all 21 questions are answered) and converted to a total score out of 100, with a minimum score of 0. Higher scores indicate better function. Total score range is 0 to 100. | 0-24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Joint pain, Ankle fracture, Leg length discrepancy, CAM boot, Even-Up