Surgery of the Pilon Fractures

NCT ID: NCT03367169

Last Updated: 2024-05-03

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

TERMINATED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-23

Study Completion Date

2024-04-26

Brief Summary

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The assessment consists in comparing the osteosynthesis plate with minimally invasive technique versus open reduction and internal fixation.

The aim of study is to compare (period of bandage, efficacy, safety), these two types of surgical technique by using a prospective, randomized analysis.

Detailed Description

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Several surgical techniques exist and among plate osteosynthesis, there is a minimally invasive method and the open reduction method.

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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Pilon Fractures Fractures Bone Leg Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking

Study Groups

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minimally invasive method

The patients are treated with minimally invasive method

Group Type ACTIVE_COMPARATOR

minimally invasive method

Intervention Type PROCEDURE

type of surgical technique

open reduction method

The patients are treated with open reduction method

Group Type ACTIVE_COMPARATOR

open reduction method

Intervention Type PROCEDURE

type of surgical technique

Interventions

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minimally invasive method

type of surgical technique

Intervention Type PROCEDURE

open reduction method

type of surgical technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* More than 18-year-old with opened or closed pilon fracture Cauchoix type 1,
* signed patient consent

Exclusion Criteria

* Open pilon fracture cauchoix type 2 or 3,
* infection of the operating site,
* previous osseous disease
* patient who are unwilling or unable to give consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

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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