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

Congenital Pseudarthrosis of Tibia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03257826
• Other study ID #: HN04
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Congenital Pseudarthrosis of Tibia
• Pseudarthrosis

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