Surgery of the Pilon Fractures (MICOPIL)

University Hospital, Clermont-Ferrand

Status: Terminated

Conditions: Leg Injuries; Fractures; Pilon Fractures; Bone

Treatments: Procedure: minimally invasive method; Procedure: open reduction method

Study type: Interventional

Funder types: Other

Identifiers

NCT03367169

2017-A01735-48 (Other Identifier)

CHU-368

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

minimally invasive method

Active Comparator group

Description:

The patients are treated with minimally invasive method

Treatment:

Procedure: minimally invasive method

open reduction method

Active Comparator group

Description:

The patients are treated with open reduction method

Treatment:

Procedure: open reduction method