Clinical trial NCT06288139: Management of Open Fracture Tibia in Teenagers
Official title: Management of Open Fracture Tibia in Teenagers in Assiut University Hospital .
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Open tíbia Fracture
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients fulfilling the inclusion criteria presenting to our hospital during the study period will be included in the study in 2024

Brief summary: The aim of this study is to study the incidence of open tibial fractures in early teenagers and evaluate the management outcomes

Detailed description: Tibial fractures are the third most common long bone fracture after the femur and forearm, representing 15% of all pediatric fractures Tibial fracture is a common injury in children, and it usually involves the diaphysis and distal metaphyseal region Open fracture tibia must be considered orthopedic emergencies due to the high risk of contamination, osteomyelitis, malformation, nonunion, and disability The anteromedial aspect of the tibia is subcutaneous with no overlying musculature for protection and the middle/distal tibia has no muscular origins, which can delay union in these areas The biology of the repair of fractures in children differs from that in adults in several ways. The soft tissues have excellent healing capacity, uncontaminated devitalised bone is salvageable and periosteum in children can regenerate bone in the presence of bone loss. Union is faster. Modalities of treatment of open fracture tibia in teenagers Including Closed reduction followed by a well- molded casting ,debridement followed by casting , utilization of external fixator (EF) remains a popular choice for open injuries, Severely comminuted and unstable fractures and those with significant soft tissue or vascular injury require external fixation However, pin tract infection (PTI) and refracture are common complications during the application of EF . Elastic Nail has also been reported with an acceptable for the treatment of open tibial fractures

, open reduction and internal fixation (ORIF) was reserved for situations in which an adequate reduction could not be obtained or maintained by conservative, Also Closed reduction and intramedullary nail fixation appropriate for the treatment of extraarticular distal tibial fractures .

Eligibility criteria: Inclusion Criteria :

• All patients presenting with isolated open fracture tibia in teenagers (aged 10 to 19 Years old )

Exclusion Criteria:

* Patient who refuse to participate in the study
* Patient less than 10 or more than 19 years old
* Pathologic fractures
* Open Fracture tibia with other bony or organ injury
* Open fracture tibia with soft tissue loss or vascular injury

Primary outcomes:
measure: Number
timeFrame: Baseline
Secondary outcomes:
measure: To evaluate treatment outcomes
timeFrame: Baseline
measure: Soft tissue healing
timeFrame: Baseline
measure: Complication
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Kamal El gafari, prof
role: STUDY_DIRECTOR
References:
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