Unreamed Intramedullary Tibial Nailing in Treatment of Open IIIa Diaphyseal Tibial Fractures in Adults

Not yet recruiting

• Conditions: Tibia Fracture

• Registration Number: NCT06280417
• Lead Sponsor: Assiut University

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 nature.Concerns 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 fixation.Despite initial encouraging results, plate fixation of open tibial fractures has been associated with implant failures, nonunions, and deep infection rates as high as 35%.6As 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 fractures.intramedullary 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 4%.other 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.

Here,our purpose is to investigate the outcome of Unreamed intramedullary nail in open diaphyseal fractures of the tibia in our setup .

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-26
• Last Update Submitted: 2024-02-26
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Study Start: 2024-06-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Open grade IIIa diaphyseal tibial fractures .
2. Skeletaly mature patients .

Exclusion Criteria

1. late presentation and open infected fractures .
2. Associated intraarticular fractures of proximal /distal tibia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of non union	Baseline	Preoperative and postoperative x-ray anteroposterior \& lateral views including both ankle and knee joints

Secondary Outcome Measures

Name	Time	Method
Incidince of fracture related infection	Baseline	Culture and sensitivity and blood tests
The rate of reoperation for delayed union or non-union , infection and fasciotomy	Baseline
functional evaluation	Baseline	Modified Karlstrom- Olerud Score