The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures
NCT ID: NCT01104831
Last Updated: 2017-05-08
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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TERMINATED
PHASE3
20 participants
INTERVENTIONAL
2010-04-30
2012-11-30
Brief Summary
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Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome measures: Satisfaction/pain relief and narcotic requirement
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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21 degree Cooling
Room temperature water circulated through cryotherapy sleeve.
Room temperature cuff
sleeve with room temperature water placed over fracture site.
10 degree cooling
Cooled water circulated through a cryotherapy sleeve.
Cryotherapy
cooled sleeve placed over fracture site.
Interventions
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Cryotherapy
cooled sleeve placed over fracture site.
Room temperature cuff
sleeve with room temperature water placed over fracture site.
Eligibility Criteria
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Inclusion Criteria
* Trauma patients with single-system musculoskeletal injuries.
* Proximal tibia fractures treated with open reduction and internal fixation.
* Unilateral proximal tibial injuries.
Exclusion Criteria
* Upper extremity injuries impairing mobilization
* Pre-existing ipsilateral neurologic condition or acute ipsilateral neurologic injury
* Associated injuries impairing mobilization
* Suspected or confirmed compartment syndrome
* Open fractures
* Patients previously on narcotics
* Patients with impaired sensorium Concurrent head injury Intoxication
17 Years
ALL
No
Sponsors
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Orthopedic Research and Education Foundation
OTHER
Orthopedic Trauma Association
UNKNOWN
University of Manitoba
OTHER
Responsible Party
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University of Manitoba
Principal Investigators
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Jesse A Shantz, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Locations
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Winnipeg Health Sciences Centre
Winnipeg, Manitoba, Canada
Countries
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Other Identifiers
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B2009:035
Identifier Type: -
Identifier Source: org_study_id
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