Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518265
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula Nails What Results for Which Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula Nails What Results for Which Patients A Monocentric Case Series
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OFCCF
Brief Summary:
Ankle fractures are among the most common injuries in orthopedic and trauma surgery accounting for 9 of all fractures They can be classified into isolated malleolar fractures internal andor external pilon fractures and distal tibia fractures which affect the entire distal part of the tibia depending on whether they are intra-articular or extra-articular
The aging of the population and the increase in survival of multiple trauma patients lead to an increase in ankle fractures with high skin risk whether due to an open fracture soft tissue injury crush dermabrasion etc or a major risk of scarring chronic venous insufficiency lymphedema unbalanced diabetes
The fibula nail is a recent minimally invasive osteosynthesis method whose results seem at least equivalent to those of screwed plate osteosynthesis in numerous series in the literature The most commonly used and most studied fibula nail in the literature is the Acumed fibula nail In recent literature the use of the fibula nail in the fixation of tibial pilon fractures andor fractures of the distal quarter of the leg is associated with satisfactory results
The elements collected as part of this study could make it possible to validate the use of the fibula nail in the management strategy for these fractures and thus better codify and standardize practices in this restricted and complex area of traumatology
The aging of the population and the increase in survival of multiple trauma patients lead to an increase in ankle fractures with high skin risk whether due to an open fracture soft tissue injury crush dermabrasion etc or a major risk of scarring chronic venous insufficiency lymphedema unbalanced diabetes
The fibula nail is a recent minimally invasive osteosynthesis method whose results seem at least equivalent to those of screwed plate osteosynthesis in numerous series in the literature The most commonly used and most studied fibula nail in the literature is the Acumed fibula nail In recent literature the use of the fibula nail in the fixation of tibial pilon fractures andor fractures of the distal quarter of the leg is associated with satisfactory results
The elements collected as part of this study could make it possible to validate the use of the fibula nail in the management strategy for these fractures and thus better codify and standardize practices in this restricted and complex area of traumatology
Detailed Description:
Ankle fractures represent one of the most common injuries in orthopedic and trauma surgery with an incidence of 9 of all fractures We distinguish between isolated fractures of the malleolus internal andor external fractures of the tibial pilon and the distal quarter of the leg which concern the entire distal part of the tibia depending on whether they are intra- or extra-articular The aging of the population and the increase in survival of multiple trauma patients lead to an increase in ankle fractures with high skin risk whether due to an open fracture soft tissue injury crush dermabrasion etc or a major risk of scarring chronic venous insufficiency lymphedema unbalanced diabetes etc
The classic management of fractures of the fibula external malleolus is based on open reduction-fixation using a screwed plate made through a longitudinal incision Restoring the length of the fibula contributes to the reduction of fractures of the tibial pilon However in patients at high skin risk plate fixation increases tissue trauma and can lead to scar complications and infections
The fibula nail is a recent minimally invasive osteosynthesis method whose results seem at least equivalent to those of screwed plate osteosynthesis in numerous series in the literature BÄCKER 2019 The most commonly used and most studied fibula nail in the literature is the Acumed fibula nail In recent literature the use of the fibula nail in the fixation of tibial pilon fractures andor fractures of the distal quarter of the leg is associated with satisfactory results
If the fibula nail seems equivalent to the screwed plate in classic ankle fractures we can wonder if its minimally invasive nature does not give it an advantage over the screwed plate in the fixation of ankle fractures high skin risk To our knowledge few series have been published concerning this subpopulation at risk and for which the fibula nail represents an interesting alternative
Likewise although a biomechanical study showed a higher rate of torsional fracture after fibula nail fixation versus screwed plate the results of fibula nail fixation in unstable ankle fractures appear equivalent to those of fixing by screwed plates As the notion of stability of ankle fractures is not clearly defined in the literature we will refer to tri-malleolar fractures dislocated bi-malleolar fractures tibial pilon fractures and fractures of the distal quarter of the leg as unstable fractures As the notion of skin risk is not clearly defined in the literature we will designate as skin risk patients presenting with acute traumatic tissue damage associated or not with an open fracture evaluated according to the Oestern and Tscherne classification as well as patients presenting with a skin disease chronic such as lipodermatosclerosis lymphedema varicose or arterial ulcer and skin atrophy secondary to long-term corticosteroid therapy compromising the healing of a longitudinal incision next to the fibula
Expected benefits
The elements collected as part of this study could make it possible to validate the use of the fibula nail in the management strategy for these fractures and thus better codify and standardize practices in this restricted and complex area of traumatology
The classic management of fractures of the fibula external malleolus is based on open reduction-fixation using a screwed plate made through a longitudinal incision Restoring the length of the fibula contributes to the reduction of fractures of the tibial pilon However in patients at high skin risk plate fixation increases tissue trauma and can lead to scar complications and infections
The fibula nail is a recent minimally invasive osteosynthesis method whose results seem at least equivalent to those of screwed plate osteosynthesis in numerous series in the literature BÄCKER 2019 The most commonly used and most studied fibula nail in the literature is the Acumed fibula nail In recent literature the use of the fibula nail in the fixation of tibial pilon fractures andor fractures of the distal quarter of the leg is associated with satisfactory results
If the fibula nail seems equivalent to the screwed plate in classic ankle fractures we can wonder if its minimally invasive nature does not give it an advantage over the screwed plate in the fixation of ankle fractures high skin risk To our knowledge few series have been published concerning this subpopulation at risk and for which the fibula nail represents an interesting alternative
Likewise although a biomechanical study showed a higher rate of torsional fracture after fibula nail fixation versus screwed plate the results of fibula nail fixation in unstable ankle fractures appear equivalent to those of fixing by screwed plates As the notion of stability of ankle fractures is not clearly defined in the literature we will refer to tri-malleolar fractures dislocated bi-malleolar fractures tibial pilon fractures and fractures of the distal quarter of the leg as unstable fractures As the notion of skin risk is not clearly defined in the literature we will designate as skin risk patients presenting with acute traumatic tissue damage associated or not with an open fracture evaluated according to the Oestern and Tscherne classification as well as patients presenting with a skin disease chronic such as lipodermatosclerosis lymphedema varicose or arterial ulcer and skin atrophy secondary to long-term corticosteroid therapy compromising the healing of a longitudinal incision next to the fibula
Expected benefits
The elements collected as part of this study could make it possible to validate the use of the fibula nail in the management strategy for these fractures and thus better codify and standardize practices in this restricted and complex area of traumatology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None