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

Primary Purpose

Congenital Pseudarthrosis of Tibia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
kirschner wire
Sponsored by
Hunan Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Pseudarthrosis of Tibia focused on measuring congenital pseudarthrosis of the tibia, age of surgery, Percutaneous Kirschner wire

Eligibility Criteria

1 Month - 12 Months (Child)All SexesAccepts 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

Sites / Locations

  • Kun LiuRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

surgery

Arm Description

Percutaneous Kirschner wire

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
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).
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.

Full Information

First Posted
August 15, 2017
Last Updated
October 20, 2020
Sponsor
Hunan Children's Hospital
Collaborators
Guangzhou Women and Children's Medical Center, Shenzhen Children's Hospital, Tongji Hospital, Wuhan Union Hospital, China, 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
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1. Study Identification

Unique Protocol Identification Number
NCT03257826
Brief Title
The Effect of Percutaneous Kirschner Wire Technique in Management of CPT Under One Year Old
Official Title
The Effect of Percutaneous Kirschner Wire Technique in Management of Congenital Pseudarthrosis of Tibia Under One Year Old
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hunan Children's Hospital
Collaborators
Guangzhou Women and Children's Medical Center, Shenzhen Children's Hospital, Tongji Hospital, Wuhan Union Hospital, China, 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Pseudarthrosis of Tibia
Keywords
congenital pseudarthrosis of the tibia, age of surgery, Percutaneous Kirschner wire

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surgery
Arm Type
Experimental
Arm Description
Percutaneous Kirschner wire
Intervention Type
Device
Intervention Name(s)
kirschner wire
Intervention Description
retrograde percutaneous kirschner wire was applied to stabilize the tibia.
Primary Outcome Measure Information:
Title
Primary union score (range,4-12 score)
Description
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)
Time Frame
9 months post-operation
Secondary Outcome Measure Information:
Title
Refracture(Cortical discontinuity)
Description
Refracture was defined as an obvious fracture(Cortical discontinuity) on a plain radiograph,following the union at the site of the tibia.
Time Frame
0.5 , 1,2,3,4,5,6,7,8,9,10 years after the fracture is healed
Title
Residual Deformity-proximal tibia angulation(range,0°-90°)
Description
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.
Time Frame
pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation ]
Title
Residual Deformity-Limb length discrepancy
Description
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).
Time Frame
pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Title
Residual Deformity-ankle valgus angulation(range,0°-90°)
Description
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.
Time Frame
pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kun Liu, MD
Phone
008615084796158
Email
lk998@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haibo Mei, MD
Phone
008613975197731
Email
meihaibo@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haibo Mei, MD
Organizational Affiliation
Hunan Children's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Kun Liu
City
Changsha
State/Province
Hunan
ZIP/Postal Code
417000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun Liu, MD
Phone
008615084796158
Email
lk998@sina.com

12. IPD Sharing Statement

Learn more about this trial

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

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