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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Uses of Titanium Nail in Pediatric Fractures

NCT06276062

Trauma Injury of Upper Extremity Forearm Multiple Fracture of Distal End of Radius

RECRUITING NA

Fixation of Shaft Femure Fracrture by Ender Versus Plate

NCT07067333

Shaft Femure Fracture in Adolescents

NOT_YET_RECRUITING NA

Titanium Elastic Nails in the Treatment of Pediatric Femur Fractures

NCT00175656

Femur Fracture

COMPLETED PHASE1

Retrospective Study on Clinical Performance and Safety Profile of Agile Nail

NCT06412939

Fractures, Bone Impending Fracture Deformity; Bone

TERMINATED

Study of Tibial Shaft Fractures in Children

NCT01238523

Tibial Shaft Fractures in Children

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Proximal Third Tibial Shaft Fractures in Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

retrograde 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes