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NCT Number: NCT06500325

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

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.

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag university Hospital

Sohag, Egypt

Location status: Recruiting

Location contact

Magdy M Amin, professor

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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.

Primary outcomes

  1. Goniometry of knee and ankle joints range of motion (ROM)

    Time frame: 1 year

    Goniometry 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marawan S Mohamed, lecturer

CONTACT

mOHAMED Y Ahmed, resident

CONTACT

[email protected]

01011367165

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.