Bone, Fractures, Leg Injuries, Pilon Fractures
Conditions
Keywords
Pilon fractures, Osteosynthesis, Mini invasive plate osteosynthesis, Locked plate, Open reduction
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.
Interventions
PROCEDUREminimally invasive method
type of surgical technique
PROCEDUREopen reduction method
type of surgical technique
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| 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) |
| Complications | pre op 45 days, 3, 6 and 12 months | list of the complications |
| Radiologic evaluation | pre op 45 days, 3, 6 and 12 months | Radiologic evaluation |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORRoger ERIVAN
University Hospital, Clermont-Ferrand
Outcome results
None listed