Lower Extremity Fractures Clinical Trial
Official title:
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
| Verified date | August 2017 |
| Source | University of Utah |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 19 |
| Est. completion date | July 10, 2017 |
| Est. primary completion date | July 10, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Utah | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| University of Utah | William Beaumont Army Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patient Activity Measure (PAM-13) Questionnaire | A subjective evaluation of perceived compliance with physician instruction | Follow Up Visits up to 1-Year | |
| Secondary | X-ray (AP and Lateral) | Subjectively evaluate fracture healing | Follow Up Visits up to 1 Year |