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TerminatedNCT03367169MICOPILUpdated Aug 5, 2026

Surgery of the Pilon Fractures

An interventional study of minimally invasive method and open reduction method in Pilon Fractures, Fractures and Bone, sponsored by University Hospital, Clermont-Ferrand. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Treatment

Why this study was terminated
recrutment problems
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 56 studies in Fractures, Bone with a site in France — 10 open to participants now, 13 under way, none of them phase 3. Fractures, Bone · France.

Enrollment
26th of 28
54 · median 130
Started
2017
with 1 other
No phase
19 of 56
4 open now
Registered
23rd of 56
by date
Lead sponsor
3 of 56
University Hospital, Clermont-Ferrand

Among the 56 studies in Fractures, Bone with a site in France, this one is the 26th largest by enrollment of the 28 interventional ones, is one of 2 that started in 2017, is one of 19 with no phase, and was the 23rd registered.

By phase

56 studies; the count open now beside each. This study's row is marked.

Observational28 · 5 open
No phasethis study19 · 4 open
Phase 24 · 1 open
Phase 2/32 · 0 open
Phase 32 · 0 open
Phase 41 · 0 open

By the year they started

First in 1994; this study’s year is marked. 2 started in 2017.

Size and results

Median enrollment 130 across the 28 interventional studies, 140 across the 28 observational. Of the 36 that completed or were terminated, 4 (11%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 56 studies in Fractures, Bone with a site in France, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Pilon Fractures
  • Fractures
  • Bone
  • Leg Injuries

Keywords

  • Pilon fractures
  • Osteosynthesis
  • Mini invasive plate osteosynthesis
  • Locked plate
  • Open reduction
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • More than 18-year-old with opened or closed pilon fracture Cauchoix type 1,
  • signed patient consent

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    minimally invasive method

    The patients are treated with minimally invasive method

    Procedure: minimally invasive method

  • Active comparator
    open reduction method

    The patients are treated with open reduction method

    Procedure: open reduction method

Interventions

  • Procedureminimally invasive method

    type of surgical technique

  • Procedureopen reduction method

    type of surgical technique

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at 45 days

Secondary outcomes

  1. 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

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

  2. 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.

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

  3. 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

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

  4. 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)

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

  5. Complications

    list of the complications

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

  6. Radiologic evaluation

    Radiologic evaluation

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

07

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

References and documents

Publications

  • Erivan R, Caputo T, Monadjemi S, Pereira B, Descamps S, Boisgard S, Villatte G. A comparison of minimally invasive plate osteosynthesis (MIPO) versus open reduction and internal fixation (ORIF) in the management of tibial pilon fractures: A prospective randomized study. Orthop Traumatol Surg Res. 2025 Nov;111(7):104323. doi: 10.1016/j.otsr.2025.104323. Epub 2025 Jun 19. PubMed 40543647 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Apr 2024, 77 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2017
First posted
Dec 8, 2017
StartActual
Nov 23, 2017
Primary completionActual
Apr 26, 2024
CompletionActual
Apr 26, 2024
Last update
Aug 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03367169
Responsible party
Sponsor
First posted
Dec 8, 2017
Start date
Nov 23, 2017
Primary completion
Apr 26, 2024
Completion
Apr 26, 2024
Last update
Aug 5, 2026

Study contacts

Roger ERIVAN
principal investigator · University Hospital, Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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