Comparison of the Minimally Invasive Surgery Versus Open Reduction in the Surgery of the Pilon Fractures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pilon Fractures
- Sponsor
- University Hospital, Clermont-Ferrand
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Healing
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Healing
Time Frame: 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 Outcomes
- AOFAS clinical score(pre op, 45 days, 3, 6 and 12 months)
- Radiologic evaluation(pre op 45 days, 3, 6 and 12 months)
- The Foot & Ankle Disability Index(pre op 45 days, 3, 6 and 12 months)
- Complications(pre op 45 days, 3, 6 and 12 months)
- Nach mazur and al score(pre op 45 days, 3, 6 and 12 months)
- Pain(pre op 45 days, 3, 6 and 12 months)