Pilon FracturesMICOPILNCT03367169
Surgery of the Pilon Fractures
A study testing minimally invasive method and open reduction method in people with Pilon Fractures and Fractures, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilon Fractures, Fractures, Bone
- What is being tested?
- minimally invasive method and open reduction method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2017to 26 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 18-year-old with opened or closed pilon fracture Cauchoix type 1,
- signed patient consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Pilon Fractures, Fractures, Bone, Leg Injuries
- Being tested
- minimally invasive method, open reduction method
- Keywords
- Pilon fractures, Osteosynthesis, Mini invasive plate osteosynthesis, Locked plate, Open reduction
- Medical subject headings
- Fractures, Bone, Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive methodProcedure or surgery
type of surgical technique
open reduction methodProcedure or surgery
type of surgical technique
| Study group | Role | What they receive |
|---|---|---|
| minimally invasive method | Active comparator | The patients are treated with minimally invasive method Receives: Procedure: minimally invasive method |
| open reduction method | Active comparator | The patients are treated with open reduction method Receives: Procedure: open reduction method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 45 days
Secondary outcomes (6)
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
Measured: 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.
Measured: 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
Measured: 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)
Measured: pre op 45 days, 3, 6 and 12 months
Complications
list of the complications
Measured: pre op 45 days, 3, 6 and 12 months
Radiologic evaluation
Radiologic evaluation
Measured: pre op 45 days, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start23 Nov 2017
- Primary completion26 Apr 2024
- Study completion26 Apr 2024
Why it stopped: recrutment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pilon FracturesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger ERIVAN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367169
- Sponsor's protocol ID
- CHU-368
- Other IDs
- 2017-A01735-48
- Acronym
- MICOPIL
- Status last verified
- Aug 2026
- First submitted
- 23 Nov 2017
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Minimally Invasive Surgery Versus Open Reduction in the Surgery of the Pilon Fractures
- ClinicalTrials.gov ID
- NCT03367169
- Acronym / sponsor ID
- MICOPIL / CHU-368
- Conditions
- Pilon Fractures, Fractures, Bone, Leg Injuries
- Keywords
- Pilon fractures, Osteosynthesis, Mini invasive plate osteosynthesis, Locked plate, Open reduction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recrutment problems
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimally invasive method | Active comparator | Procedure: minimally invasive methodThe patients are treated with minimally invasive method |
| open reduction method | Active comparator | Procedure: open reduction methodThe patients are treated with open reduction method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- More than 18-year-old with opened or closed pilon fracture Cauchoix type 1,
- signed patient consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minimally invasive methodtype of surgical technique | Procedure or surgery | minimally invasive method |
| open reduction methodtype of surgical technique | Procedure or surgery | open reduction method |
Primary outcome
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.
6 secondary outcomes
AOFAS clinical score
Time frame: pre op, 45 days, 3, 6 and 12 months
Nach mazur and al score
Time frame: pre op 45 days, 3, 6 and 12 months
The Foot & Ankle Disability Index
Time frame: pre op 45 days, 3, 6 and 12 months
Pain
Time frame: pre op 45 days, 3, 6 and 12 months
Complications
Time frame: pre op 45 days, 3, 6 and 12 months
Radiologic evaluation
Time frame: pre op 45 days, 3, 6 and 12 months
Results and safety
The study was stopped early (reason given: recrutment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publication: PubMed 40543647Erivan 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.
Related trials for Pilon Fractures
Recruiting
Talar Osteochondral Lesions With Pilon Fractures
Pilon Fractures
Recruiting
Simplified Post Op Rehabilitation for Ankle and Pilon Fractures
Ankle Fractures, Pilon Fracture
RecruitingPhase 4
Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)
Pilon Fracture
Not yet recruitingPhase 1
Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging.
Achilles Tendon Repairs/Reconstructions, Pilon Fracture of Tibia
RecruitingObservational study
FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)
Ankle Fractures, Pilon Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger ERIVAN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimally invasive method and open reduction method in people with Pilon Fractures and Fractures, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recrutment problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing (time frame: at 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03367169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.