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

NCT ID: NCT03257826

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2022-12-01

Brief Summary

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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

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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.

Conditions

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Congenital Pseudarthrosis of Tibia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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surgery

Percutaneous Kirschner wire

Group Type EXPERIMENTAL

kirschner wire

Intervention Type DEVICE

retrograde percutaneous kirschner wire was applied to stabilize the tibia.

Interventions

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kirschner wire

retrograde percutaneous kirschner wire was applied to stabilize the tibia.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Shenzhen Children's Hospital

OTHER_GOV

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Wuhan Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Foshan Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Dalian Children's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Kunming Children's Hospital

OTHER

Sponsor Role collaborator

Hunan Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haibo Mei, MD

Role: STUDY_DIRECTOR

Hunan Children's Hospital

Locations

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Kun Liu

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kun Liu, MD

Role: CONTACT

008615084796158

Haibo Mei, MD

Role: CONTACT

008613975197731

Facility Contacts

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Kun Liu, MD

Role: primary

008615084796158

Other Identifiers

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HN04

Identifier Type: -

Identifier Source: org_study_id

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