Comparison of titanium elastic nail, external fixator and casting on prevention of complications in closed diaphyseal tibial fracture

Comparison of titanium elastic nail, external fixator and casting on prevention of complications in closed diaphyseal tibial fracture in children between 5-12 years old

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190127042514N4

Enrollment

120

Registered

2020-02-28

Start date

2017-09-11

Completion date

Unknown

Last updated

2020-03-24

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

Conditions

Diaphyseal closed tibia fracture.

Interventions

Intervention 1: Intervention group 1: Patients treated with titanium elastic nail : After choosing the appropriate anesthesia method, the patient was placed supine. The surgical technique began with a

Eligibility

Sex/Gender

All

Age

5 Years to 12 Years

Inclusion criteria

Inclusion criteria: Being at the age of 5-12 years old Closed diaphyseal fracture of the tibia

Exclusion criteria

Exclusion criteria: Open fracture Pathological fracture Metabolic disease Congenital deformities of the skeletal system

Design outcomes

Primary

Measure	Time frame
Patient satisfaction. Timepoint: 2, 6 and 12 months later. Method of measurement: Using the Medical Outcomes Study Short Form 12 (SF-12) and Oxford Score questionnaire according to surgical outcome criteria.;Non fusion. Timepoint: 2, 6 and 12 months later. Method of measurement: Imaging evaluation.;Refracture. Timepoint: 2, 6 and 12 months later. Method of measurement: Imaging evaluation.;Angulation. Timepoint: 2, 6 and 12 months later. Method of measurement: Imaging evaluation.;Infection. Timepoint: 2, 6 and 12 months later. Method of measurement: Physical examination.;Bone length difference (up to 1 cm). Timepoint: 2, 6 and 12 months later. Method of measurement: Imaging evaluation and physical examination.	—

Measure

Time frame

Patient satisfaction. Timepoint: 2, 6 and 12 months later. Method of measurement: Using the Medical Outcomes Study Short Form 12 (SF-12) and Oxford Score questionnaire according to surgical outcome criteria.;Non fusion. Timepoint: 2, 6 and 12 months later. Method of measurement: Imaging evaluation.;Refracture. Timepoint: 2, 6 and 12 months later. Method of measurement: Imaging evaluation.;Angulation. Timepoint: 2, 6 and 12 months later. Method of measurement: Imaging evaluation.;Infection. Timepoint: 2, 6 and 12 months later. Method of measurement: Physical examination.;Bone length difference (up to 1 cm). Timepoint: 2, 6 and 12 months later. Method of measurement: Imaging evaluation and physical examination.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmirreza Mirzaei Sosafidi

Kerman University of Medical Sciences

amirreza.mirzaei@live.com+98 34 3223 5011

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026