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

Sponsor

Hunan Children's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03257826

Collaborator

Guangzhou Women and Children's Medical Center (Other), Shenzhen Children's Hospital (Other), Tongji Hospital (Other), Wuhan Union Hospital, China (Other), Wuhan Women and Children's Medical Center (Other), Foshan Hospital of Traditional Chinese Medicine (Other), Dalian Children's Hospital (Other), Children's Hospital of Chongqing Medical University (Other), Kunming Children's Hospital (Other)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Pseudarthrosis of Tibia	Device: kirschner wire	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: surgery

Percutaneous Kirschner wire

Device: kirschner wire

retrograde percutaneous kirschner wire was applied to stabilize the tibia.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

1 Month to 12 Months

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kun Liu	Changsha	Hunan	China	417000

Investigators

Study Director: Haibo Mei, MD, Hunan Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hunan Children's Hospital

ClinicalTrials.gov Identifier:

NCT03257826

Other Study ID Numbers:

HN04

First Posted:

Aug 22, 2017

Last Update Posted:

Oct 22, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hunan Children's Hospital

congenital pseudarthrosis of the tibia

age of surgery