Actively Recruiting

Phase Not Applicable
Age: 4Years - 12Years
All Genders
Healthy Volunteers
NCT06500325

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

Led by Sohag University · Updated on 2024-07-15

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 4Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged between 4 and 12 years
  • Patients with traumatic proximal shaft tibia fractures that are closed or open up to Gustillo grade II
Not Eligible

You will not qualify if you...

  • Children with Gustillo grade III A, B, or C open fractures
  • Children with pathological fractures

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sohag university Hospital

Sohag, Egypt

Actively Recruiting

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Research Team

M

mOHAMED Y Ahmed, resident

CONTACT

M

Marawan S Mohamed, lecturer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

0

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