Clinical trial NCT04164563: Even-Up to Minimize Secondary Site Pain For Ankle Fracture
Official title: A Randomized Controlled Trial of Non-Operative Ankle Fractures: Even-Up Orthotic Shoe Lift and CAM Walking Boot Wear
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthralgia
Trouble Balancing
Keywords: Joint pain
Ankle fracture
Leg length discrepancy
CAM boot
Even-Up
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Reported Pain (VAS)
timeFrame: 0-24 weeks
measure: Patient Reported Outcome (FAAM-ADL, 0 - 100)
timeFrame: 0-24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jeremy T Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
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