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

Not Applicable

• Conditions: Congenital Pseudarthrosis of Tibia
• Interventions: Device: kirschner wire

• Registration Number: NCT03257826
• Lead Sponsor: Hunan Children's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-08-01
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-19
• Study First Posted: 2017-08-22
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
surgery	kirschner wire	Percutaneous Kirschner wire

Primary Outcome Measures

Name	Time	Method
Primary union score (range,4-12 score)	9 months post-operation	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)

Secondary Outcome Measures

Name	Time	Method
Residual Deformity-proximal tibia angulation(range,0°-90°)	pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation ]	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.
Residual Deformity-Limb length discrepancy	pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation	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).
Residual Deformity-ankle valgus angulation(range,0°-90°)	pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation	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.
Refracture（Cortical discontinuity)	0.5 , 1,2,3,4,5,6,7,8,9,10 years after the fracture is healed	Refracture was defined as an obvious fracture（Cortical discontinuity) on a plain radiograph,following the union at the site of the tibia.

Trial Locations

Locations (1)

Kun Liu; 🇨🇳 Changsha, Hunan, China