Distal Tibial Fracture, Tibial Fracture, Fracture Fixation, Intramedullary, Fracture Fixation, Internal, Bone Plates, Adolescents
Conditions
Keywords
Distal tibial fracture, Metaphyseal-diaphyseal junction, Adolescent fractures, Elastic stable intramedullary nailing, Kirschner wires, Plate fixation
Brief summary
This prospective randomized controlled trial will compare two surgical methods for treating distal tibial metaphyseal-diaphyseal junction fractures in adolescents aged 10 to 16 years. Participants will be randomly assigned in a 1:1 ratio to receive either elastic stable intramedullary nailing supplemented by Kirschner wires or plate fixation. The study will compare fracture healing, radiological alignment, time to full weight-bearing, functional outcomes, and treatment-related complications. Participants will be followed at 2 weeks, 6 weeks, 3 months, and 6 months after surgery.
Detailed description
Distal tibial metaphyseal-diaphyseal junction fractures in adolescents can be difficult to treat because of the short distal fragment, proximity to the growth plate, and tendency toward displacement and malalignment. Elastic stable intramedullary nailing is minimally invasive and preserves the fracture biology, but fixation of the short distal fragment may be less stable. Supplementary Kirschner wires may improve rotational and angular stability. Plate fixation provides stable fixation and good control of alignment but may require greater soft-tissue dissection. This study will be conducted at the Department of Orthopaedics Surgery, Sohag University Hospital. Eligible adolescents with displaced or unstable distal tibial metaphyseal-diaphyseal junction fractures requiring surgical fixation will be randomly assigned to one of two treatment groups. Group A will undergo elastic stable intramedullary nailing supplemented by one or two Kirschner wires. Group B will undergo plate fixation using a distal tibial locking compression plate. Randomization will be performed using a computer-generated sequence in a 1:1 ratio. Patients will undergo clinical and radiological follow-up at 2 weeks, 6 weeks, 3 months, and 6 months. The primary outcomes are time to radiological union and fracture union rate. Secondary outcomes include coronal and sagittal alignment, time to full weight-bearing, AOFAS Ankle-Hindfoot Score, Lower Extremity Functional Scale, and complications including malunion, delayed union, nonunion, infection, implant irritation or failure, and reoperation.
Interventions
PROCEDUREElastic Stable Intramedullary Nailing Supplemented by Kirschner Wires
Closed reduction will be performed under fluoroscopic guidance. Two appropriately sized titanium elastic nails will be inserted through medial and lateral entry points in the proximal tibial metaphysis and advanced across the fracture into the distal fragment. One or two supplementary Kirschner wires will then be inserted percutaneously across the distal fragment under fluoroscopic guidance to enhance rotational and angular stability.
PROCEDUREPlate fixation
Following fracture reduction, fixation will be performed using a distal tibial locking compression plate through a minimally invasive plate osteosynthesis technique or a limited open approach according to fracture characteristics. The plate will be positioned on the medial aspect of the tibia and secured with appropriate locking and cortical screws under fluoroscopic guidance.
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Age 10-16 years. * Patients diagnosed with distal tibial metaphyseal-diaphyseal junction (DTDMJ) fractures. * Closed fractures or Gustilo-Anderson type I open fractures. * Acute fractures presenting within two weeks of injury. * Displaced or unstable fractures requiring surgical fixation. * Open or partially open physis, as assessed on preoperative radiographs.
Exclusion criteria
* Patients younger than 10 years or older than 16 years. * Fractures involving the distal tibial physis (Salter-Harris fractures). * Intra-articular distal tibial fractures. * Gustilo-Anderson type II and III open fractures. * Pathological fractures. * Fractures associated with metabolic bone disease or congenital skeletal disorders. * Polytrauma patients requiring alternative treatment priorities. * Previous fracture, deformity, or surgical intervention involving the affected tibia. * Neurovascular injury requiring repair.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Radiological Union | From surgery through 6 months | Time from surgery to radiographic evidence of fracture union as assessed on follow-up anteroposterior and lateral radiographs. |
| Fracture Union Rate | At 6 months | Proportion of participants demonstrating radiological fracture union during postoperative follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coronal and Sagittal Alignment | At 2 weeks, 6 weeks, 3 months, and 6 months | Radiographic assessment of coronal and sagittal alignment of the distal tibia during postoperative follow-up. |
| Time to Full Weight-Bearing | From surgery through 6 months | Time from surgery until the participant is allowed to progress to full weight-bearing based on fracture stability and radiographic evidence of healing. |
| AOFAS Ankle-Hindfoot Score | During postoperative follow-up through 6 months | Functional outcome assessed using the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score. The total score ranges from 0 to 100 points, including pain, function, and alignment, with higher scores indicating better outcome. |
| Lower Extremity Functional Scale | During postoperative follow-up through 6 months | Functional outcome assessed using the Lower Extremity Functional Scale (LEFS), a patient-reported measure evaluating difficulty with daily activities such as walking, running, and climbing stairs. The maximum score is 80 points, with higher scores indicating better lower-extremity function. |
| Treatment-Related Complication Rate | From surgery through 6 months | Proportion of participants experiencing treatment-related complications, including malunion, delayed union, nonunion, superficial infection, deep infection, implant irritation, implant failure, or reoperation. |
Countries
Egypt
Outcome results
None listed