Insole Sensor to Determine Optimal Limb Loading

Development and Clinical Trial of an Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of OTA Type 42IIIB and IIIC Lower Extremity Fractures

The purpose of this study is to use a novel load monitoring technology to correlate limb loading to OTA type 42IIIB and IIIC tibial fracture outcomes. This study will be the first to collect continuous limb loading data and will provide the first objective insight into how limb loading directs fracture healing. To meet this purpose, two specific aims have been developed.

Specific Aim 1: Preclinical validation of a load-monitoring insole

The Hitchcock laboratory has overcome the greatest technical hurdle for continuous limb load monitoring: development of load sensor technology that is affordable, accurate and capable of monitoring for over four weeks. To develop this sensor technology into a load-monitoring insole, the Hitchcock lab will incorporate consumer type electronics into the design, including a microprocessor, battery, and data storage media.

Following construction of a functional load-monitoring insole, a pilot human study with orthopaedic trauma patients from the University of Utah (N=20) will be conducted to identify modes of device failure, improve device interfacing and develop data handling protocols and software for the clinical arm of the proposed study.

Specific Aim 2: Conduct a prospective, direct observational cohort study.

Thirty (30) open tibial fracture patients will be recruited at two centers: University of Utah (N=15) and William Beaumont Army Medical Center (N=15). Participants will wear a walking boot instrumented with the load-monitoring insole that will continuously record limb loading and serve as a step counter. X-rays collected at standard-of-care follow-up visits will be used by Drs. Kubiak and Orr to subjectively evaluate fracture healing. A questionnaire regarding subjective perception of patient compliance will be collected at the first and last follow-up visits. Data collected from the insole sensor will be correlated to objective measures of fracture healing and subjective measures of patient compliance to determine the effect of patient limb loading on injury outcome. The Hitchcock laboratory will develop software to process and summarize data from the load monitoring insole and continually improve human interfacing factors of the load monitoring insole based off of feedback from the clinical team and study participants.

Study Overview

• Status: Completed
• Conditions: Lower Extremity Fractures

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah

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 with an Open Tibial Fractures.

Description

Inclusion Criteria:

Specific Aim 1 Inclusion Criteria

• Patient is 18 years of age or older
• Patient has below the knee fracture
• Patient speaks English
• Patient weighs between 100 and 250 pounds
• Patient lives in close enough proximity to the the hospital to return for all appointments (~100 miles)

Specific Aim 2 Inclusion Criteria

• Patient is 18 years of age or older
• Patient has a tibia fracture
• Patient speaks English
• Patient weighs between 100 and 250 pounds
• Patient lives in close enough proximity to the the hospital to return for all appointments (~100 miles)

Exclusion Criteria:

Specific Aim 1 Exclusion Criteria

• Patient is younger than 18 years of age
• Patient does not have a below the knee fracture
• 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 another fracture that will alter his/her weight bearing status

Specific Aim 2 Exclusion Criteria

• Patient is younger than 18 years of age
• Patient does not have a tibia fracture
• 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 another fracture that will alter his/her weight bearing status

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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 instruction	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
• Collaborators: William Beaumont Army Medical Center
• Investigators: Principal Investigator: David Rothberg, MD, Orthopedic Surgery

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 10, 2017
• Study Completion (Actual): July 10, 2017

Study Registration Dates

• First Submitted: June 18, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 23, 2014

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

• Keywords: Insole Sensor; Optimial Limb Loading; 42IIIB; IIIC; Lower Extremity Fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 58956