NCT06500325 Results of Retrograde Titanium Elastic Nails for Fixation of Proximal Third Tibial Shaft Fractures in Children.
| NCT ID | NCT06500325 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sohag University |
| Condition | Proximal Third Tibial Shaft Fractures in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2024-10-01 |
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 50 participants in total. It began in 2023-10-01 with a primary completion date of 2024-10-01.
⚠ 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
Pediatric tibial shaft fracture is the third most common pediatric long bone fracture after fracture of femur and forearm, representing 15% of all pediatric fractures. Closed reduction and casting is the standard of care for stable and minimally displaced fracture of the tibia in pediatric age group. Treatment of pediatric fractures dramatically changed in 1982. The goals are to stabilize the fracture, control limb length, alignment, rotation, instability, promote bone healing, and minimize the morbidity and complications for the child and his/her family. Titanium elastic nails (TENs) fixation was originally meant as an ideal treatment method for femoral shaft fractures, but was gradually applied to other long bones diaphysial fractures in children, as it represents a compromise between conservative and surgical therapeutic approaches with satisfactory results and minimal complications. Over the past 20 years, pediatric orthopedic surgeons have tried a variety of methods to treat pediatric lower limb fractures to avoid prolonged immobilization and complications. Each method has had its own complications: cast immobilization alone or following traction had resulted in limb-length discrepancy, angulations, rotational deformity, psychological and economic complications. External fixation had resulted in pin-tract infection, loss of knee range of motion, delayed union, non-union, and refracture after fixator removal. TENs work by balancing the forces between the two opposing flexible implants. To achieve this balance, the nail diameter should be 40% of the narrowest canal diameter or more. The nails should assume a double-C construct. They should have similar smooth curve and same level entry points. Ligier et al and Flynn et al have reported that TENs can give rotational stability if good care is taken intra-operatively during nail insertion and postoperatively, especially for comminuted, spiral, and long oblique fractures.
Eligibility Criteria
Inclusion Criteria: * Inclusion Criteria included children are patients presented with traumatic proximal shaft tibia fracture closed or open up to Gustillo grade II and patients between 4 and 12. Exclusion Criteria: * Exclusion criteria excluded children presented with Gustillo grade III A, B \& C open fractures and pathological fractures.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06500325 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 12 Years, studying Proximal Third Tibial Shaft Fractures in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06500325 currently recruiting?
Yes, NCT06500325 is actively recruiting participants. Contact the research team at mohamed_yousry_post@med.sohag.edu.eg for enrollment information.
Where is the NCT06500325 trial being conducted?
This trial is being conducted at Sohag, Egypt.
Who is sponsoring the NCT06500325 clinical trial?
NCT06500325 is sponsored by Sohag University. The trial plans to enroll 50 participants.