Surgery of the Pilon Fractures (MICOPIL)

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

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.

Study Overview

• Status: Terminated
• Conditions: Leg Injuries; Bone; Fractures; Pilon Fractures
• Intervention / Treatment: Procedure: minimally invasive method; Procedure: open reduction method

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: minimally invasive method; The patients are treated with minimally invasive method	Procedure: minimally invasive method; type of surgical technique
Active Comparator: open reduction method; The patients are treated with open reduction method	Procedure: open reduction method; type of surgical technique

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Roger ERIVAN, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2017
• Primary Completion (Actual): April 26, 2024
• Study Completion (Actual): April 26, 2024

Study Registration Dates

• First Submitted: November 23, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Estimated): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Osteosynthesis; Pilon fractures; Open reduction; Mini invasive plate osteosynthesis; Locked plate
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Leg Injuries
• Other Study ID Numbers: CHU-368; 2017-A01735-48 (Other Identifier: 2017-A01735-48)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No