Skip to content

Results of Retrograde Titanium Elastic Nails for Fixation of Proximal Third Tibial Shaft Fractures in Children.

Results of Retrograde Titanium Elastic Nails for Fixation of Proximal Third Tibial Shaft Fractures in Children.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06500325
Enrollment
50
Registered
2024-07-15
Start date
2023-10-01
Completion date
2024-10-01
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Third Tibial Shaft Fractures in Children

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.

Interventions

PROCEDUREretrograde titanium elastic nails for fixation of proximal third tibial shaft fractures in children

Two TENs were used in all cases using the double-C construct in most cases to gain three point of fixation. The starting point for nail insertion is 1.5-2.0 cm proximal to the physis of distal tibia. Both nails are then inserted through the entry holes and advanced to pass the level of the fracture site to achieve fixation. The two incisions for nail entry are closed in a layered fashion, and the wounds are well padded with gauze.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes

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

*

Design outcomes

Primary

MeasureTime frameDescription
Goniometry of knee and ankle joints range of motion (ROM)1 yearGoniometry involves using a goniometer, which is a specialized protractor-like device, to measure the angles of movement at joints such as the knee and ankle.

Countries

Egypt

Contacts

Primary ContactmOHAMED Y Ahmed, resident
mohamed_yousry_post@med.sohag.edu.eg01011367165
Backup ContactMarawan S Mohamed, lecturer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026