Clinical trial NCT06280417: Unreamed Intramedullary Tibial Nailing in Treatment of Open IIIa Diaphyseal Tibial Fractures in Adults
Official title: Unreamed Intramedullary Tibial Nailing in Treatment of Open IIIa Diaphyseal Tibial Fractures in Adults
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Tibia Fracture
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting with type IIIa diaphyseal tibial fractures are included in the study

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of non union
timeFrame: Baseline
Secondary outcomes:
measure: Incidince of fracture related infection
timeFrame: Baseline
measure: The rate of reoperation for delayed union or non-union , infection and fasciotomy
timeFrame: Baseline
measure: functional evaluation
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
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citation: Schade AT, Sabawo M, Nyamulani N, Mpanga CC, Ngoie LB, Metcalfe AJ, Lalloo DG, Madan JJ, Harrison WJ, MacPherson P. Functional outcomes and quality of life at 1-year follow-up after an open tibia fracture in Malawi: a multicentre, prospective cohort study. Lancet Glob Health. 2023 Oct;11(10):e1609-e1618. doi: 10.1016/S2214-109X(23)00346-7. Epub 2023 Sep 1.
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