Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521606
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Comparison of Temporary External Fixation and Open Reduction With Internal Fixation for the Management of Pilon Fracture A Prospective Clinical Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Temporary External Fixation and Open Reduction With Internal Fixation for the Management of Pilon Fracture A Prospective Clinical Trial
Status:
COMPLETED
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:
None
Brief Summary:
Pilon fractures are among the difficult injuries to treat in orthopedic surgery Treatment approaches should consider associated soft tissue injuries The two main treatment modalities are a two-stage procedure secondary open reduction internal fixation ORIF and primary external fixation and one-stage ORIF The latter is widely agreed upon in the literature In the present study we contrasted the outcomes of these two approaches
Detailed Description:
Pilon fractures are responsible for 1 of lower limb fractures and 5-7 of tibial fractures The optimal treatment for these fractures has remained challenging and complicated despite significant advancements in recent years in the management of these fractures mostly because of severely injured soft tissue severe edema and a high-energy fracture pattern As a result selecting an appropriate course of treatment is still debatable
Early after the injury the subcutaneous soft tissue and local skin condition determine whether a direct method and open reconstruction of the articular surface are safe Early surgical treatment through a flimsy soft tissue envelope raises the possibility of wound complications promotes infection and may even result in limb amputation
The idea of postponing the ultimate osteosynthesis till after the cutaneous condition has been improved came to the forefront in the 1990s Adopted techniques stressed thorough soft-tissue care in conjunction with delayed definitive fixation to minimize additional damage to surrounding soft tissues Both long- and short-term outcomes showed decreased surgical complications
Pilon fractures result from two different force types that can either act individually or concurrently The primary force is axial compression resulting in the talus being driven into the tibial plafond this frequently results in concomitant damage to the talar dome The secondary force type is rotation producing variable degrees of articular shearing and fracture fragment displacement A clear distinction should be made between these two different forces because the relative contribution of each affects the severity of the fracture soft tissue damage and prognosis
The medial fragment which comprises the medial malleolus and the nearby weight-bearing segment the Chaput or anterolateral fragment and the Volkman or posterolateral fragment typically with their ligamentous attachments intact are the three variable yet predictable fragments that make up the most specific fracture pattern Where the implant will be put and eventually the surgical approaches that will be employed is influenced by the position of the articular segments the location of the fracture lines as they exit the cortex and whether or not those parts are continuous with the intact tibial shaft
The anterolateral quarter of the articular surface and the central corridor of the plafond apex are frequent locations for areas of comminution As a result in most patients an anterior approach provides better access to comminution zones and an anterolateral distal tibia plate may be employed to strengthen the comminution zone Although they occur in various planes the three primary fracture fragments anterolateral medial and posterior are not sufficiently fixed by a single plate Most anterolateral plates are insufficiently designed to capture the medial fragment
Therefore Phillip Penny et al stated Given the wide range of pilon fractures in various patient populations it is doubtful that a single plate could maintain a sufficient reduction Hence it may be best to use a combination of plating techniques to stabilize distal tibia fractures while reinforcing comminution areas
The results of treating pilon fractures are generally still not satisfactory Infections non-union delayed union and soft tissue healing complications are common These complications are mainly caused by the anatomical features of this region which include limited soft tissue coverage and an insufficient blood supply Another factor is that such fractures are frequently the result of violent accidents that severely bruise the skin blood vessels and muscles Moreover in almost two-thirds of cases arthritis might develop after surgical intervention for pilon fractures
This study aims to evaluate the feasibility advantages and disadvantages of temporary external fixation for pilon fractures and compare its outcomes with cases that will be managed with primary open reduction and internal fixation ORIF
Early after the injury the subcutaneous soft tissue and local skin condition determine whether a direct method and open reconstruction of the articular surface are safe Early surgical treatment through a flimsy soft tissue envelope raises the possibility of wound complications promotes infection and may even result in limb amputation
The idea of postponing the ultimate osteosynthesis till after the cutaneous condition has been improved came to the forefront in the 1990s Adopted techniques stressed thorough soft-tissue care in conjunction with delayed definitive fixation to minimize additional damage to surrounding soft tissues Both long- and short-term outcomes showed decreased surgical complications
Pilon fractures result from two different force types that can either act individually or concurrently The primary force is axial compression resulting in the talus being driven into the tibial plafond this frequently results in concomitant damage to the talar dome The secondary force type is rotation producing variable degrees of articular shearing and fracture fragment displacement A clear distinction should be made between these two different forces because the relative contribution of each affects the severity of the fracture soft tissue damage and prognosis
The medial fragment which comprises the medial malleolus and the nearby weight-bearing segment the Chaput or anterolateral fragment and the Volkman or posterolateral fragment typically with their ligamentous attachments intact are the three variable yet predictable fragments that make up the most specific fracture pattern Where the implant will be put and eventually the surgical approaches that will be employed is influenced by the position of the articular segments the location of the fracture lines as they exit the cortex and whether or not those parts are continuous with the intact tibial shaft
The anterolateral quarter of the articular surface and the central corridor of the plafond apex are frequent locations for areas of comminution As a result in most patients an anterior approach provides better access to comminution zones and an anterolateral distal tibia plate may be employed to strengthen the comminution zone Although they occur in various planes the three primary fracture fragments anterolateral medial and posterior are not sufficiently fixed by a single plate Most anterolateral plates are insufficiently designed to capture the medial fragment
Therefore Phillip Penny et al stated Given the wide range of pilon fractures in various patient populations it is doubtful that a single plate could maintain a sufficient reduction Hence it may be best to use a combination of plating techniques to stabilize distal tibia fractures while reinforcing comminution areas
The results of treating pilon fractures are generally still not satisfactory Infections non-union delayed union and soft tissue healing complications are common These complications are mainly caused by the anatomical features of this region which include limited soft tissue coverage and an insufficient blood supply Another factor is that such fractures are frequently the result of violent accidents that severely bruise the skin blood vessels and muscles Moreover in almost two-thirds of cases arthritis might develop after surgical intervention for pilon fractures
This study aims to evaluate the feasibility advantages and disadvantages of temporary external fixation for pilon fractures and compare its outcomes with cases that will be managed with primary open reduction and internal fixation ORIF
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