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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-07-13

Brief Summary

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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.

Detailed Description

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Conditions

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Ankle Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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David Rothberg

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Rothberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah Orthopedics Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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73982

Identifier Type: -

Identifier Source: org_study_id