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OpenTrials
Terminated

NCT Number: NCT03367169

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.

Why the study stopped: recrutment problems
Terminated

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Key information

Conditions

Pilon Fractures Bone Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

minimally invasive method

Procedure

type of surgical technique

open reduction method

Procedure

type of surgical technique

Primary outcomes

  1. 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

  1. AOFAS clinical score

    Time frame: 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

  2. Nach mazur and al score

    Time frame: 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.

  3. The Foot & Ankle Disability Index

    Time frame: 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

  4. Pain

    Time frame: 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)

  5. Complications

    Time frame: pre op 45 days, 3, 6 and 12 months

    list of the complications

  6. Radiologic evaluation

    Time frame: pre op 45 days, 3, 6 and 12 months

    Radiologic evaluation

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: MICOPIL

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2017
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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