Even-Up to Minimize Secondary Site Pain For Ankle Fracture

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

Patrocinadores

Patrocinador principal: Brigham and Women's Hospital

Fuente Brigham and Women's Hospital
Resumen breve

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.

Descripción detallada

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.

Estado general Recruiting
Fecha de inicio November 14, 2019
Fecha de Terminación December 31, 2020
Fecha de finalización primaria December 31, 2020
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Patient reported pain 0-24 weeks
Patient reported outcome 0-24 weeks
Inscripción 100
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Even-Up

Descripción: Orthotic shoe lift worn on contralateral foot to increase leg length

Etiqueta de grupo de brazo: Study

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Jeremy T Smith, MD Principal Investigator Brigham and Women's Hospital
Contacto general

Apellido: Jeremy T Smith, MD

Teléfono: 617-983-7295

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Brigham and Women's Hospital Jeremy T Smith, MD [email protected]
Ubicacion Paises

United States

Fecha de verificación

July 2020

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Brigham and Women's Hospital

Nombre completo del investigador: Jeremy Smith

Título del investigador: Assistant Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Control

Tipo: No Intervention

Descripción: Standard CAM boot treatment without Even-Up device.

Etiqueta: Study

Tipo: Experimental

Descripción: CAM boot treatment with Even-Up for contralateral extremity.

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: Randomized controlled trial

Propósito primario: Prevention

Enmascaramiento: None (Open Label)

Descripción de enmascaramiento: Both patients and providers are aware that patients are being assigned to either control or experimental group.

Fuente: ClinicalTrials.gov