Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-01-01 @ 8:24 PM
Study NCT ID:
NCT03367169
Status:
TERMINATED
Last Update Posted:
2024-05-03
First Post:
2017-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery of the Pilon Fractures
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Comparison of the Minimally Invasive Surgery Versus Open Reduction in the Surgery of the Pilon Fractures
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recrutment problems
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MICOPIL
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-A01735-48 | OTHER | 2017-A01735-48 | View |