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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03257826
Other study ID # HN04
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2015
Est. completion date December 1, 2022

Study information

Verified date October 2020
Source Hunan Children's Hospital
Contact Kun Liu, MD
Phone 008615084796158
Email lk998@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 12 Months
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
kirschner wire
retrograde percutaneous kirschner wire was applied to stabilize the tibia.

Locations

Country Name City State
China Kun Liu Changsha Hunan

Sponsors (10)

Lead Sponsor Collaborator
Hunan Children's Hospital Children's Hospital of Chongqing Medical University, Dalian Children's Hospital, Foshan Hospital of Traditional Chinese Medicine, Guangzhou Women and Children's Medical Center, Kunming Children's Hospital, Shenzhen Children's Hospital, Tongji Hospital, Wuhan Union Hospital, China, Wuhan Women and Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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 ]
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT02896114 - A Retrospective Study of Surgical Treatment of Congenital Pseudarthrosis of Tibia in China
Active, not recruiting NCT05693558 - NVD-003 in the Treatment of Congenital Pseudarthrosis of the Tibia Phase 1
Terminated NCT02718131 - A Study of INFUSE Bone Graft (BMP-2) in the Treatment of Tibial Pseudarthrosis in Neurofibromatosis Type 1 (NF1) N/A
Recruiting NCT02640040 - The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia N/A