NCT07783529 Elastic Nailing With Kirschner Wires Versus Plate Fixation for Distal Tibial Fractures in Adolescents
| NCT ID | NCT07783529 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sohag University |
| Condition | Distal Tibial Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-07-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07783529 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 16 Years, studying Distal Tibial Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07783529 currently recruiting?
Yes, NCT07783529 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sohag University to inquire about joining.
Where is the NCT07783529 trial being conducted?
This trial is being conducted at Sohag, Egypt.
Who is sponsoring the NCT07783529 clinical trial?
NCT07783529 is sponsored by Sohag University. The trial plans to enroll 60 participants.