Surgery of the Pilon Fractures
- Conditions
- BoneLeg InjuriesPilon FracturesFractures
- Interventions
- Procedure: minimally invasive methodProcedure: open reduction method
- Registration Number
- NCT03367169
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 54
- More than 18-year-old with opened or closed pilon fracture Cauchoix type 1,
- signed patient consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description minimally invasive method minimally invasive method The patients are treated with minimally invasive method open reduction method open reduction method The patients are treated with open reduction method
- Primary Outcome Measures
Name Time Method Healing at 45 days Measure of the duration of the bandage with index form of follow-up the state cutaneous of the wound. This measure was a number.
- Secondary Outcome Measures
Name Time Method AOFAS clinical score pre op, 45 days, 3, 6 and 12 months 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
Radiologic evaluation pre op 45 days, 3, 6 and 12 months Radiologic evaluation
Complications pre op 45 days, 3, 6 and 12 months list of the complications
The Foot & Ankle Disability Index pre op 45 days, 3, 6 and 12 months 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
Nach mazur and al score pre op 45 days, 3, 6 and 12 months 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.
Pain pre op 45 days, 3, 6 and 12 months 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)
Trial Locations
- Locations (1)
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France