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

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.

Study Overview

• Status: Unknown
• Conditions: Congenital Pseudarthrosis of Tibia
• Intervention / Treatment: Device: kirschner wire

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kun Liu, MD; Phone Number: 008615084796158; Email: lk998@sina.com
• Study Contact Backup: Name: Haibo Mei, MD; Phone Number: 008613975197731; Email: meihaibo@sina.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 417000
      • Recruiting
      • Kun Liu
      • Contact: Kun Liu, MD; Phone Number: 008615084796158; Email: lk998@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: surgery; Percutaneous Kirschner wire	Device: kirschner wire; retrograde percutaneous kirschner wire was applied to stabilize the tibia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 ]
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
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

Collaborators and Investigators

• Sponsor: Hunan Children's Hospital
• Collaborators: Tongji Hospital; Wuhan Union Hospital, China; Kunming Children's Hospital; Guangzhou Women and Children's Medical Center; Shenzhen Children's Hospital; Children's Hospital of Chongqing Medical University; Wuhan Women and Children's Medical Center; Foshan Hospital of Traditional Chinese Medicine; Dalian Children's Hospital
• Investigators: Study Director: Haibo Mei, MD, Hunan Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 19, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: congenital pseudarthrosis of the tibia; age of surgery; Percutaneous Kirschner wire
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Ununited; Pseudarthrosis
• Other Study ID Numbers: HN04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No