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

NCT03257826 — Not applicable, Unknown, 100 participants, Hunan Children's Hospital

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

RegistryNCT03257826
StatusUnknown
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment100 (Estimated)
SponsorHunan Children's Hospital (Other gov); collaborators: Guangzhou Women and Children's Medical Center, Shenzhen Children's Hospital, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Women and Children's Medical Center, Foshan Hospital of Traditional Chinese Medicine, Dalian Children's Hospital, Children's Hospital of Chongqing Medical University, Kunming Children's Hospital
ConditionsCongenital Pseudarthrosis of Tibia
Interventionskirschner wire (Device)
Datesstart 2015-08-01, primary completion 2022-12-01 (estimated), completion 2022-12-01 (estimated), first posted 2017-08-22, last updated 2020-10-22
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Congenital Pseudarthrosis of Tibia All trials of kirschner wire

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
surgeryExperimentalDevice: kirschner wirePercutaneous Kirschner wire
  • kirschner wire (Device): retrograde percutaneous kirschner wire was applied to stabilize the tibia.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.
  • 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.

+Eligibility

Sex: All, ages: 1 Month to 12 Months, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Kun LiuChangsha, HunanChinaRecruiting

+Investigators