Clinical trial NCT03257826: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Pseudarthrosis of Tibia
Keywords: congenital pseudarthrosis of the tibia
age of surgery
Percutaneous Kirschner wire
Lead sponsor: Hunan Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Guangzhou Women and Children's Medical Center
name: Shenzhen Children's Hospital
name: Tongji Hospital
name: Wuhan Union Hospital, China
name: Wuhan Women and Children's Medical Center
name: Foshan Hospital of Traditional Chinese Medicine
name: Dalian Children's Hospital
name: Children's Hospital of Chongqing Medical University
name: Kunming Children's Hospital
First posted: 2017-08-22
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Primary union score (range,4-12 score)
timeFrame: 9 months post-operation
Secondary outcomes:
measure: Refracture（Cortical discontinuity)
timeFrame: 0.5 , 1,2,3,4,5,6,7,8,9,10 years after the fracture is healed
measure: Residual Deformity-proximal tibia angulation(range,0°-90°)
timeFrame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation ]
measure: Residual Deformity-Limb length discrepancy
timeFrame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
measure: Residual Deformity-ankle valgus angulation(range,0°-90°)
timeFrame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Other outcomes:
Locations:
city: Changsha
country: China
facility: Kun Liu
state: Hunan
Study officials:
affiliation: Hunan Children's Hospital
name: Haibo Mei, MD
role: STUDY_DIRECTOR
References: