Insole Sensor to Determine Optimal Limb Loading

NCT02170493 | Completed

• 1 other identifier: 58956
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Extremity Fractures

Keywords

Insole Sensor; Optimial Limb Loading; 42IIIB; IIIC; Lower Extremity Fractures

Outcome Measures

Primary Outcomes (1)

• Patient Activity Measure (PAM-13) Questionnaire

  A subjective evaluation of perceived compliance with physician instruction

  Follow Up Visits up to 1-Year

Secondary Outcomes (1)

• X-ray (AP and Lateral)

  Follow Up Visits up to 1 Year

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present to the University of Utah with an Open Tibial Fractures.

You may qualify if:

• 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)
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Utah: lead
• William Beaumont Army Medical Center: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Study Officials

• David Rothberg, MD

  Orthopedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 23, 2014
• Study Start: January 1, 2013
• Primary Completion: July 10, 2017
• Study Completion: July 10, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-08

Locations

US (1)