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

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

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.

Study Overview

• Status: Completed
• Conditions: Ankle Fracture

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84121
      • University Of Utah Orthopedics Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who present to the University of Utah emergency department with ankle fractures.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Activity Measure (PAM-13) Questionnaire	A subjective evaluation of perceived compliance with physician instructions	Follow Up Visits up to 1-Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
X-ray (AP and Lateral)	Subjectively evaluate fracture healing	Follow Up Visits up to 1-Year

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: David Rothberg, M.D., University of Utah

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): July 13, 2017
• Study Completion (Actual): July 13, 2017

Study Registration Dates

• First Submitted: January 6, 2015
• First Submitted That Met QC Criteria: January 6, 2015
• First Posted (Estimate): January 8, 2015

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: 73982