The Effect of Percutaneous Kirschner Wire Technique in Management of CPT Under One Year Old

Study Overview
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Brief Summary
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The aim of this study was to investigate the effect of percutaneous kirschner wire in management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. This study was to determine the union rates of congenital pseudarthrosis in children operated before 1 year of age to identify growth abnormalities in the affected limb ,including ankle valgus,tibia valgus,and shortening.

Detailed Description
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Currently, the timing of surgery for congenital pseudarthrosis of the tibia is a controversial issue. The investigators use percutaneous kirschner wire technique to manage the Congenital Pseudarthrosis of Tibia in children younger than 1 year of age.To investigate the effect of percutaneous kirschner wire in management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. Bone uion rate,average time of healing, ankle valgus, limb length discrepancy, tibia axis alignment are recorded and evaluated.

Official Title
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The Effect of Percutaneous Kirschner Wire Technique in Management of Congenital Pseudarthrosis of Tibia Under One Year Old

Conditions
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Congenital Pseudarthrosis of Tibia

Intervention / Treatment
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* Device: kirschner wire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients did not undergo procedures Patients with Crawford type IV CPT treated with Percutaneous Kirschner wire techniques The age during surgery was less than 12 months old Exclusion Criteria: Patients with pseudarthrosis of tibia caused by trauma,infection, etc

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgery<br>Percutaneous Kirschner wire | Device: kirschner wire<br>* retrograde percutaneous kirschner wire was applied to stabilize the tibia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary union score (range,4-12 score) | X ray score from tibia pseudarthrosis in anterior and posterior (AP )and lateral X ray. (RUST score:radiographic union scoring system for tibial fracture healing) | 9 months post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refracture（Cortical discontinuity) | Refracture was defined as an obvious fracture（Cortical discontinuity) on a plain radiograph,following the union at the site of the tibia. | 0.5 , 1,2,3,4,5,6,7,8,9,10 years after the fracture is healed | 
| Residual Deformity-proximal tibia angulation(range,0°-90°) | measurement of the angulation of proximal tibia in anterior and posterior (AP )and lateral X ray.Proximal tibial valgus is created by the intersection of a line parallel to the proximal physis and another line along the axis of the proximal third of diaphysis in the tibia. | pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation ] | 
| Residual Deformity-Limb length discrepancy | measurement of the length difference of both tibia in AP and lateral X ray.Picture Archiving and Communication System (PACS) is used to measure the length of the tibia (The investigators measure the distance between the midpoint of the proximal tibial epiphyseal plate and the midpoint of distal tibia epiphyseal plate). | pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation | 
| Residual Deformity-ankle valgus angulation(range,0°-90°) | measurement of the angulation between the distal tibia and ankle joint.Ankle valgus is assessed by the tibiotalar angle measured at the intersection of the mid-diaphyseal line of the tibia and a line drawn across the flat subchondral line of the talar dome. | pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital pseudarthrosis of the tibia, age of surgery, Percutaneous Kirschner wire