Surgery of the Pilon Fractures

Study Overview
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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.

Official Title
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Comparison of the Minimally Invasive Surgery Versus Open Reduction in the Surgery of the Pilon Fractures

Conditions
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Pilon Fractures, Fractures, Bone, Leg Injuries

Intervention / Treatment
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* Procedure: minimally invasive method
* Procedure: open reduction method


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: minimally invasive method<br>The patients are treated with minimally invasive method | Procedure: minimally invasive method<br>* type of surgical technique<br>|
| Active Comparator: open reduction method<br>The patients are treated with open reduction method | Procedure: open reduction method<br>* type of surgical technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 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) | pre op 45 days, 3, 6 and 12 months | 
| Complications | list of the complications | pre op 45 days, 3, 6 and 12 months | 
| Radiologic evaluation | Radiologic evaluation | pre op 45 days, 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteosynthesis, Mini invasive plate osteosynthesis, Locked plate, Open reduction, Pilon fractures