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NCT02170493 · ClinicalTrials.gov registry record
Insole Sensor to Determine Optimal Limb Loading
A clinical trial, sponsored by University of Utah.
- Completed
- Registry status
- 19
- Enrollment target
NCT02170493: Completed study, sponsored by University of Utah.
NCT02170493 is a clinical trial that has completed, run by University of Utah. The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02170493 has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- 19 participants
- Enrollment target
Study 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 ef
Primary Outcome
A subjective evaluation of perceived compliance with physician instruction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2013-01 |
| Est. Completion | 2017-07-10 |
What the finished NCT02170493 record still lists
NCT02170493 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 19 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02170493 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02170493 about?
NCT02170493 is a clinical study titled "Insole Sensor to Determine Optimal Limb Loading". 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 fract...
What is the current status of trial NCT02170493?
This trial is currently completed. The enrollment target is 19 participants. The study started on 2013-01. Estimated completion is 2017-07-10.
Who is sponsoring clinical trial NCT02170493?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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