Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06280417
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-20
Brief Title:
Unreamed Intramedullary Tibial Nailing in Treatment of Open IIIa Diaphyseal Tibial Fractures in Adults
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Unreamed Intramedullary Tibial Nailing in Treatment of Open IIIa Diaphyseal Tibial Fractures in Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
To study the incidence of non union of Unreamed intramedullary nailing in type IIIa Open diaphyseal fractures of the tibia as a primary outcome and the incidence of complications and clinical and functional outcome as a secondary outcome
Detailed Description:
Tibia is one of the most common bones to sustain open injury because of its superficial natureConcerns over the high rates of malunion nonunion and deep infection have resulted in the development of aggressive treatment protocols including emergent wound exploration thorough irrigation and debridement bony stabilization judicious antibiotic therapy repeated wound debridements and early soft-tissue coverage However there is still controversy regarding the optimal method of skeletal stabilization High rates of pin tract infections poor patient compliance and malunion rates of 20 and greater have limited the use of external fixators as a definitive form of fixationDespite initial encouraging results plate fixation of open tibial fractures has been associated with implant failures nonunions and deep infection rates as high as 356As a result locked intramedullary nailing has become the standard treatment for open tibia fractures enabling axial alignment early weight bearing and immediate knee and ankle motion Despite this the complications including a high incidence of local bony necrosis and sepsis that occur following reamed intramedullary nails have led some to discourage the use of this method of skeletal stabilization in open tibia fracturesintramedullary tibial nail insertion without reaming has the advantage of minimal endosteal blood supply disruption and thus supposed to have increased union rate and reduction of infection rate
Sanders et al 11 reported on the treatment of 64 patients with open tibial shaft fractures using unreamed interlocked intramedullary nails All but 1 of the fractures healed with excellent alignment and an overall chronic infection rate of 4other studies reported similar results 12 type and timing of fixation were important determinants of infection with people who received intramedullary nailing within 24 h having the lowest risk of infection UTN significantly reduced the incidence rates of superficial infection and malunion compared with EF suggesting that it is likely a safe and effective alternative to EF for treating open tibial fractures however patients postoperative weight bearing should be controlled to avoid hardware failure
Hereour purpose is to investigate the outcome of Unreamed intramedullary nail in open diaphyseal fractures of the tibia in our setup
Sanders et al 11 reported on the treatment of 64 patients with open tibial shaft fractures using unreamed interlocked intramedullary nails All but 1 of the fractures healed with excellent alignment and an overall chronic infection rate of 4other studies reported similar results 12 type and timing of fixation were important determinants of infection with people who received intramedullary nailing within 24 h having the lowest risk of infection UTN significantly reduced the incidence rates of superficial infection and malunion compared with EF suggesting that it is likely a safe and effective alternative to EF for treating open tibial fractures however patients postoperative weight bearing should be controlled to avoid hardware failure
Hereour purpose is to investigate the outcome of Unreamed intramedullary nail in open diaphyseal fractures of the tibia in our setup
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?:
None