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
NA
54 participants
INTERVENTIONAL
2017-11-23
2024-04-26
Brief Summary
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The aim of study is to compare (period of bandage, efficacy, safety), these two types of surgical technique by using a prospective, randomized analysis.
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Detailed Description
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Investigators think that the minimally invasive method with intern plate is more efficient than the open reduction method.
These techniques may better preserve perifracture soft tissues, hematoma. It may lead to a smaller muscle detachment.
The minimally invasive technique allows a more efficient vascularization of the fracture site, what would increase bone healing and the functional prognosis of tibial pilon lesions.
It's all these issues investigators would like to assess with a randomized study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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minimally invasive method
The patients are treated with minimally invasive method
minimally invasive method
type of surgical technique
open reduction method
The patients are treated with open reduction method
open reduction method
type of surgical technique
Interventions
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minimally invasive method
type of surgical technique
open reduction method
type of surgical technique
Eligibility Criteria
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Inclusion Criteria
* signed patient consent
Exclusion Criteria
* infection of the operating site,
* previous osseous disease
* patient who are unwilling or unable to give consent
18 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Roger ERIVAN
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Other Identifiers
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2017-A01735-48
Identifier Type: OTHER
Identifier Source: secondary_id
CHU-368
Identifier Type: -
Identifier Source: org_study_id
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