Distal Tibial FractureNCT07783529
Elastic Nailing With Kirschner Wires Versus Plate Fixation for Distal Tibial Fractures in Adolescents
A study testing Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires and Plate fixation in people with Distal Tibial Fracture and Tibial Fracture, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Distal Tibial Fracture, Tibial Fracture, Fracture Fixation, Intramedullary
- What is being tested?
- Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires and Plate fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- Polytrauma patients requiring alternative treatment priorities.
- Previous fracture, deformity, or surgical intervention involving the affected tibia.
- Neurovascular injury requiring repair.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag, Sohag Governorate, 82749
Mohamed S Hassan, M.B.B.Ch., 01060318567, mohamed.farghaly@med.sohag.edu.eg
Sumayya M Mohamed, M.B.B.Ch., 01016571202, su5221225@gmail.com
About this study
Official title: Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires Versus Plate Fixation in the Treatment of Distal Tibial Metaphyseal-diaphyseal Junction Fractures in Adolescents
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.
Read the 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.
- Conditions
- Distal Tibial Fracture, Tibial Fracture, Fracture Fixation, Intramedullary, Fracture Fixation, Internal, Bone Plates, Adolescents
- Being tested
- Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires, Plate fixation
- Keywords
- Distal tibial fracture, Metaphyseal-diaphyseal junction, Adolescent fractures, Elastic stable intramedullary nailing, Kirschner wires, Plate fixation
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic Stable Intramedullary Nailing Supplemented by Kirschner WiresProcedure or surgery
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.
Plate fixationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ESIN Supplemented by Kirschner Wires | Experimental | Participants assigned to this arm will undergo elastic stable intramedullary nailing using two appropriately sized elastic titanium nails inserted through medial and lateral proximal tibial metaphyseal entry points. One or two supplementary Kirschner wires will then be inserted percutaneously across the distal fragment under fluoroscopic guidance to improve rotational and angular stability. Receives: Procedure: Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires |
| Plate Fixation | Active comparator | Participants assigned to this arm will undergo fixation with a distal tibial locking compression plate using 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 fixed with appropriate locking and cortical screws under fluoroscopic guidance. Receives: Procedure: Plate fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Radiological Union
Time from surgery to radiographic evidence of fracture union as assessed on follow-up anteroposterior and lateral radiographs.
Measured: From surgery through 6 months
Fracture Union Rate
Proportion of participants demonstrating radiological fracture union during postoperative follow-up.
Measured: At 6 months
Secondary outcomes (5)
Coronal and Sagittal Alignment
Radiographic assessment of coronal and sagittal alignment of the distal tibia during postoperative follow-up.
Measured: At 2 weeks, 6 weeks, 3 months, and 6 months
Time to Full Weight-Bearing
Time from surgery until the participant is allowed to progress to full weight-bearing based on fracture stability and radiographic evidence of healing.
Measured: From surgery through 6 months
AOFAS Ankle-Hindfoot Score
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.
Measured: During postoperative follow-up through 6 months
Lower Extremity Functional Scale
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.
Measured: During postoperative follow-up through 6 months
Treatment-Related Complication Rate
Proportion of participants experiencing treatment-related complications, including malunion, delayed union, nonunion, superficial infection, deep infection, implant irritation, implant failure, or reoperation.
Measured: From surgery through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Jul 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Tibial FractureStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sabry Farghaly, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783529
- Sponsor's protocol ID
- SOH-MED-2026-001
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires Versus Plate Fixation in the Treatment of Distal Tibial Metaphyseal-diaphyseal Junction Fractures in Adolescents
- ClinicalTrials.gov ID
- NCT07783529
- Acronym / sponsor ID
- SOH-MED-2026-001
- Conditions
- Distal Tibial Fracture, Tibial Fracture, Fracture Fixation, Intramedullary, Fracture Fixation, Internal, Bone Plates, Adolescents
- Keywords
- Distal tibial fracture, Metaphyseal-diaphyseal junction, Adolescent fractures, Elastic stable intramedullary nailing, Kirschner wires, Plate fixation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESIN Supplemented by Kirschner Wires | Experimental | Procedure: Elastic Stable Intramedullary Nailing Supplemented by Kirschner WiresParticipants assigned to this arm will undergo elastic stable intramedullary nailing using two appropriately sized elastic titanium nails inserted through medial and lateral proximal tibial metaphyseal entry points. One or two supplementary Kirschner wires will then be inserted percutaneously across the distal fragment under fluoroscopic guidance to improve rotational and angular stability. |
| Plate Fixation | Active comparator | Procedure: Plate fixationParticipants assigned to this arm will undergo fixation with a distal tibial locking compression plate using 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 fixed with appropriate locking and cortical screws under fluoroscopic guidance. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elastic Stable Intramedullary Nailing Supplemented by Kirschner WiresClosed 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. | Procedure or surgery | ESIN Supplemented by Kirschner Wires |
| Plate fixationFollowing 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. | Procedure or surgery | Plate Fixation |
Primary outcome
Time to Radiological Union
Time frame: 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
Time frame: At 6 months
Proportion of participants demonstrating radiological fracture union during postoperative follow-up.
5 secondary outcomes
Coronal and Sagittal Alignment
Time frame: At 2 weeks, 6 weeks, 3 months, and 6 months
Time to Full Weight-Bearing
Time frame: From surgery through 6 months
AOFAS Ankle-Hindfoot Score
Time frame: During postoperative follow-up through 6 months
Lower Extremity Functional Scale
Time frame: During postoperative follow-up through 6 months
Treatment-Related Complication Rate
Time frame: From surgery through 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires and Plate fixation in people with Distal Tibial Fracture and Tibial Fracture, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Radiological Union (time frame: From surgery through 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.