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Surgery of the Pilon Fractures (MICOPIL)

Primary Purpose

Pilon Fractures, Fractures, Bone

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
minimally invasive method
open reduction method
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilon Fractures focused on measuring Pilon fractures, Osteosynthesis, Mini invasive plate osteosynthesis, Locked plate, Open reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

minimally invasive method

open reduction method

Arm Description

The patients are treated with minimally invasive method

The patients are treated with open reduction method

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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
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)
Complications
list of the complications
Radiologic evaluation
Radiologic evaluation

Full Information

First Posted
November 23, 2017
Last Updated
November 25, 2022
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03367169
Brief Title
Surgery of the Pilon Fractures
Acronym
MICOPIL
Official Title
Comparison of the Minimally Invasive Surgery Versus Open Reduction in the Surgery of the Pilon Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2017 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilon Fractures, Fractures, Bone, Leg Injuries
Keywords
Pilon fractures, Osteosynthesis, Mini invasive plate osteosynthesis, Locked plate, Open reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
No masking
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
minimally invasive method
Arm Type
Active Comparator
Arm Description
The patients are treated with minimally invasive method
Arm Title
open reduction method
Arm Type
Active Comparator
Arm Description
The patients are treated with open reduction method
Intervention Type
Procedure
Intervention Name(s)
minimally invasive method
Intervention Description
type of surgical technique
Intervention Type
Procedure
Intervention Name(s)
open reduction method
Intervention Description
type of surgical technique
Primary Outcome Measure Information:
Title
Healing
Description
Measure of the duration of the bandage with index form of follow-up the state cutaneous of the wound. This measure was a number.
Time Frame
at 45 days
Secondary Outcome Measure Information:
Title
AOFAS clinical score
Description
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
Time Frame
pre op, 45 days, 3, 6 and 12 months
Title
Nach mazur and al score
Description
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.
Time Frame
pre op 45 days, 3, 6 and 12 months
Title
The Foot & Ankle Disability Index
Description
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
Time Frame
pre op 45 days, 3, 6 and 12 months
Title
Pain
Description
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)
Time Frame
pre op 45 days, 3, 6 and 12 months
Title
Complications
Description
list of the complications
Time Frame
pre op 45 days, 3, 6 and 12 months
Title
Radiologic evaluation
Description
Radiologic evaluation
Time Frame
pre op 45 days, 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 10 81
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger ERIVAN
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Roger ERIVAN

12. IPD Sharing Statement

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Surgery of the Pilon Fractures

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