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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03257826
Enrollment
100
Registered
2017-08-22
Start date
2015-08-01
Completion date
2022-12-01
Last updated
2020-10-22

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

Conditions

Congenital Pseudarthrosis of Tibia

Keywords

congenital pseudarthrosis of the tibia, age of surgery, Percutaneous Kirschner wire

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.

Interventions

retrograde percutaneous kirschner wire was applied to stabilize the tibia.

Sponsors

Guangzhou Women and Children's Medical Center
CollaboratorOTHER
Shenzhen Children's Hospital
CollaboratorOTHER_GOV
Tongji Hospital
CollaboratorOTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
CollaboratorOTHER
Wuhan Women and Children's Medical Center
CollaboratorOTHER
Foshan Hospital of Traditional Chinese Medicine
CollaboratorOTHER
Dalian Children's Hospital
CollaboratorOTHER
Children's Hospital of Chongqing Medical University
CollaboratorOTHER
Kunming Children's Hospital
CollaboratorOTHER
Hunan Children's Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Primary union score (range,4-12 score)9 months post-operationX 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

MeasureTime frameDescription
Refracture(Cortical discontinuity)0.5 , 1,2,3,4,5,6,7,8,9,10 years after the fracture is healedRefracture was defined as an obvious fracture(Cortical discontinuity) on a plain radiograph,following the union at the site of the tibia.
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 discrepancypre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operationmeasurement 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-operationmeasurement 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.

Countries

China

Contacts

Primary ContactKun Liu, MD
lk998@sina.com008615084796158
Backup ContactHaibo Mei, MD
meihaibo@sina.com008613975197731

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026