An interventional study of kirschner wire in Congenital Pseudarthrosis of Tibia, sponsored by Hunan Children's Hospital. Status unknown at 1 site in China. Open to participants aged 1 Month to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by Hunan Children's Hospital · Not applicable, Interventional, and Treatment
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.
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.
41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.
This study's planned enrollment of 100 is above the median of 22 across 25 interventional studies indexed under Pseudarthrosis.
Browse Pseudarthrosis studies →Hunan Children's Hospital is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Percutaneous Kirschner wire
Device: kirschner wire
retrograde percutaneous kirschner wire was applied to stabilize the tibia.
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)
Time frame: 9 months post-operation
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Hunan Children's Hospital