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
Patrocinador principal: Brigham and Women's Hospital
|Fuente||Brigham and Women's Hospital|
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.
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.
|Fecha de inicio||November 14, 2019|
|Fecha de Terminación||December 31, 2020|
|Fecha de finalización primaria||December 31, 2020|
|Tipo de estudio||Interventional|
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
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
- Non-operative Treatment of Ankle Fracture
- CAM boot as treatment for injury
- Weight bearing ad lib
- Non-English speaking
- Recent surgery for lower extremity or back
- Recent other injury to lower extremity or back
- Restricted weight bearing
Edad mínima: 18 Years
Edad máxima: N/A
Voluntarios Saludables: Accepts Healthy Volunteers
Apellido: Jeremy T Smith, MD
Email: [email protected]
|Fecha de verificación||
Tipo: Principal Investigator
Afiliación del investigador: Brigham and Women's Hospital
Nombre completo del investigador: Jeremy Smith
Título del investigador: Assistant Professor
|Tiene acceso ampliado||No|
|Número de brazos||2|
|Grupo de brazo||
Tipo: No Intervention
Descripción: Standard CAM boot treatment without Even-Up device.
Descripción: CAM boot treatment with Even-Up for contralateral extremity.
|Datos del paciente||No|
|Información de diseño del estudio||
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.