Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436365
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2024-05-24
Brief Title:
Is the Expert Nail With Poller Screws Superior to the Distal Tibial Locked Plate in the Management of Short Oblique Distal Tibial Fractures
Sponsor:
Kasr El Aini Hospital
Organization:
Kasr El Aini Hospital
Study Overview
Official Title:
Is the Expert Nail With Poller Screws Superior to the Distal Tibial Locked Plate in the Management of Short Oblique Distal Tibial Fractures
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Distal tibial fracture management is difficult because of poor blood supply resulted from subcutaneous location Therefore the study aims to compare expert intramedullary nail IMN with poller screws to the distal tibial locked plate regarding operative and complications outcomes
Detailed Description:
Stabilization of the fractured segments is the main goal in fracture fixation which will help to achieve proper healing fasten early mobility and get the full function of the injured limb The fractures may be managed conservatively or by fixation whether internal or external
Tibial fractures are the most common long bone fractures because of their subcutaneous location which makes them more liable to trauma They are more common in young males as they are related to sports and traffic accidents Elderly people come in second place of tibial fractures because they are more likely to occur from simple falls Proper surgical management of displaced tibial fracture will help in increasing bone stability with the surrounding tissue and improving the bone alignment which in turn fastens the early movement increases overall function and prevents prolonged bedridden
Distal tibia fractures represent from 7 to 10 of all lower limb fractures Basically there is controversy over the use of the term distal tibial fractures Some authors use the term to describe the distal metaphyseal fractures as defined by one Muller square as Giannoudis 2015 et al Others use distal tibial fractures to refer to distal shaft fractures meta-diaphyseal region from 4 to 11 centimeters starting from the plafond as Polat 2015 et al Others use the term for both regions describing them as two muller squares as Mauffrey 2012 et al
Management of distal tibial fracture management is difficult especially in old patients with mature skeletons and without involvement of knee joint because of a fracture near the position to the ankle joint with decreased blood flow resulting from the subcutaneous anatomical location 8 There are common fixation techniques performed in distal tibial fracture management like open reduction with internal fixation intramedullary nail insertion IMN minimally invasive percutaneous plate osteosynthesis and external fixation with limited open reduction and internal fixation
Despite these different management methods achieving success in proper reduction and enhancing the stability and union they were associated with disadvantages that need to be considered during the management plan which makes no single method ideally preferred for all combined bone and soft tissue distal tibial traumas Therefore studies should address all advantages disadvantages and the proper application of each method
We aim in our study to compare expert IMN with poller screws to the distal tibial locked plates in the management of the short oblique distal tibial fractures regarding clinical outcomes radiological findings complications and the need for a secondary operation
Tibial fractures are the most common long bone fractures because of their subcutaneous location which makes them more liable to trauma They are more common in young males as they are related to sports and traffic accidents Elderly people come in second place of tibial fractures because they are more likely to occur from simple falls Proper surgical management of displaced tibial fracture will help in increasing bone stability with the surrounding tissue and improving the bone alignment which in turn fastens the early movement increases overall function and prevents prolonged bedridden
Distal tibia fractures represent from 7 to 10 of all lower limb fractures Basically there is controversy over the use of the term distal tibial fractures Some authors use the term to describe the distal metaphyseal fractures as defined by one Muller square as Giannoudis 2015 et al Others use distal tibial fractures to refer to distal shaft fractures meta-diaphyseal region from 4 to 11 centimeters starting from the plafond as Polat 2015 et al Others use the term for both regions describing them as two muller squares as Mauffrey 2012 et al
Management of distal tibial fracture management is difficult especially in old patients with mature skeletons and without involvement of knee joint because of a fracture near the position to the ankle joint with decreased blood flow resulting from the subcutaneous anatomical location 8 There are common fixation techniques performed in distal tibial fracture management like open reduction with internal fixation intramedullary nail insertion IMN minimally invasive percutaneous plate osteosynthesis and external fixation with limited open reduction and internal fixation
Despite these different management methods achieving success in proper reduction and enhancing the stability and union they were associated with disadvantages that need to be considered during the management plan which makes no single method ideally preferred for all combined bone and soft tissue distal tibial traumas Therefore studies should address all advantages disadvantages and the proper application of each method
We aim in our study to compare expert IMN with poller screws to the distal tibial locked plates in the management of the short oblique distal tibial fractures regarding clinical outcomes radiological findings complications and the need for a secondary operation
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?:
False
Is an FDA AA801 Violation?:
None