Study Results
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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COMPLETED
6 participants
OBSERVATIONAL
2015-08-31
2018-03-14
Brief Summary
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Detailed Description
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Severe fractures in the lower limb are associated with high energy trauma in both civilian and military patients,and are sometimes treated with external fixation devices to stabilize the bone until healing has occurred. The devices are kept on the patient for up to a year or more at significant cost, intrusiveness, and risk of infection. The clinician must decide when to remove the device such that adequate healing has occurred and the bone will not re-fracture, but healing rates are variable and x-rays can be misleading. The clinician must also identify when a patient is starting to progress poorly and an early revision surgery is needed to prevent further complications.
The investigators' goal is to develop novel approaches for instrumenting and collecting mechanical data from orthopaedic braces and devices, and identifying new methodologies for interpreting this large volume of functional data for optimizing personalized treatment. The present study is focused on external fixators. Strain gauges will be adhered to the fixators so that fixator forces can be measured during clinical visits. In this pilot study the investigators will develop methods to predict healing based on these measured forces.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Force monitoring of external fixator struts
Eligibility Criteria
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Inclusion Criteria
2. Patients scheduled to undergo or currently undergoing treatment at Hershey Medical Center for tibia fracture and/or defect using a circular external fixator including Ilizarov and Taylor Spatial Frame types.
3. Ability to perform study procedures including ambulation (with assistance device if needed)
Exclusion Criteria
2. Axially stable fracture
3. Inability to understand English
4. Inability to provide informed consent
5. Difficulty maintaining follow-up
18 Years
80 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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Gregory S. Lewis
Assistant Professor
Principal Investigators
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Gregory Lewis, PhD
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
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Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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Other Identifiers
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STUDY00002137
Identifier Type: -
Identifier Source: org_study_id
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