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

NCT03257826 | Unknown

• 1 other identifier: HN04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Pseudarthrosis of Tibia

Keywords

congenital pseudarthrosis of the tibia; age of surgery; Percutaneous Kirschner wire

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Refracture（Cortical discontinuity)

  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°)

  pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation ]

• Residual Deformity-Limb length discrepancy

  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°)

  pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation

Study Arms (1)

surgery

EXPERIMENTAL

Percutaneous Kirschner wire

Device: kirschner wire

Interventions

kirschner wire DEVICE

retrograde percutaneous kirschner wire was applied to stabilize the tibia.

surgery

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patients with pseudarthrosis of tibia caused by trauma,infection, etc

Sponsors & Collaborators

• Hunan Children's Hospital: lead
• Guangzhou Women and Children's Medical Center: collaborator
• Shenzhen Children's Hospital: collaborator
• Tongji Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Wuhan Women and Children's Medical Center: collaborator
• Foshan Hospital of Traditional Chinese Medicine: collaborator
• Dalian Children's Hospital: collaborator
• Children's Hospital of Chongqing Medical University: collaborator
• Kunming Children's Hospital: collaborator

Study Sites (1)

Kun Liu

Changsha, Hunan, 417000, China

RECRUITING

MeSH Terms

Interventions

Bone Wires

Intervention Hierarchy (Ancestors)

Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Haibo Mei, MD

  Hunan Children's Hospital

  STUDY DIRECTOR

Central Study Contacts

Kun Liu, MD

CONTACT

008615084796158; lk998@sina.com

Haibo Mei, MD

CONTACT

008613975197731; meihaibo@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 22, 2017
• Study Start: August 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

CN (1)