Surgery of the Pilon Fractures

University Hospital, Clermont-Ferrand54 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pilon Fractures Fractures Bone Leg Injuries

Interventions

minimally invasive methodPROCEDURE

type of surgical technique

open reduction methodPROCEDURE

type of surgical technique

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Outcomes

Primary Outcomes

Healing

Measure of the duration of the bandage with index form of follow-up the state cutaneous of the wound. This measure was a number.

Time frame: at 45 days

Secondary Outcomes

AOFAS clinical score

American Orthopedic Foot and Ankle Society was a standard method of reporting clinical status of the ankle and foot. The systems incorporate both subjective and objective factors into numerical scales to describe function, alignment, and pain. The score varies between 0 and 100, more the value is better brought up is the score

Time frame: pre op, 45 days, 3, 6 and 12 months

Nach mazur and al score

The Nach mazur grading system uses 100 points to assess pain, function while wearing shoes and the range of ankle movement. The maximum score a patient with a solid ankle fusion.

Time frame: pre op 45 days, 3, 6 and 12 months

The Foot & Ankle Disability Index

The Foot and Ankle Disability Index (FADI) was designed to assess functional limitations related to foot and ankle conditions. Subjective reports of function are classified as generic or specific measures, which include condition-specific, population-specific, and patient-specific instruments. The FADI have a total point value of 100 points, more the value is better brought up is the score

Time frame: pre op 45 days, 3, 6 and 12 months

Pain

THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10)

Time frame: pre op 45 days, 3, 6 and 12 months

Complications

Data from ClinicalTrials.gov

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