Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures

Ankle Fracture Clinical Trial

Official title:

Clinical Trial of an Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334618
• Other study ID #: 73982
• Status: Completed
• Phase: N/A
• First received: January 6, 2015
• Last updated: October 24, 2017
• Start date: August 2014
• Est. completion date: July 13, 2017

Study information

• Verified date: August 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to use a novel load monitoring technology to correlate limb loading to ankle fracture outcomes. This study will collect continuous limb loading data and will provide the first objective insight into how limb loading directs fracture healing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 13, 2017
• Est. primary completion date: July 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patient is 18 years of age or older

• Patient has an ankle fracture

• Patient speaks English

• Patient weighs between 100 and 250 pounds

• Patient lives in close enough proximity to the hospital to return for all appointments (~100 miles)

Exclusion Criteria:

• Patient is younger than 18 years of age

• Patient has multiple fractures that would alter weight bearing protocol

• Patient does not speak English

• Patient weighs less than 100 pounds or more than 250 pounds

• Patient does not live in close enough proximity to the hospital to return for all appointments (~>100 miles)

• Patient has a traumatic brain injury that would make it so they cannot consent

• Patient has diabetes

Related Conditions & MeSH terms

• Ankle Fracture
• Ankle Fractures
• Fractures, Bone

Locations

Country	Name	City	State
United States	University of Utah Orthopedics Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Activity Measure (PAM-13) Questionnaire	A subjective evaluation of perceived compliance with physician instructions	Follow Up Visits up to 1-Year
Secondary	X-ray (AP and Lateral)	Subjectively evaluate fracture healing	Follow Up Visits up to 1-Year