Surgery of the Pilon Fractures

Fractures Clinical Trial

— MICOPIL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03367169
• Other study ID #: CHU-368
• Secondary ID: 2017-A01735-48
• Status: Terminated
• Phase: N/A
• Start date: November 23, 2017
• Est. completion date: April 26, 2024

Study information

• Verified date: April 2024
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: April 26, 2024
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone
• Fractures
• Fractures, Bone
• Leg Injuries
• Pilon Fractures

Intervention

Procedure:
• minimally invasive method
type of surgical technique
• open reduction method
type of surgical technique

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Complications	list of the complications	pre op 45 days, 3, 6 and 12 months
Secondary	Radiologic evaluation	Radiologic evaluation	pre op 45 days, 3, 6 and 12 months