The Effect of Percutaneous Kirschner Wire Technique in Management of Congenital Pseudarthrosis of Tibia Under One Year Old
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hunan Children's Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Primary union score (range,4-12 score)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Month to 12 Months (Child)
- Sex
- 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
Outcomes
Primary Outcomes
Primary union score (range,4-12 score)
Time Frame: 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 Outcomes
- 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)
- Refracture（Cortical discontinuity)(0.5 , 1,2,3,4,5,6,7,8,9,10 years after the fracture is healed)