Congenital Pseudarthrosis of Tibia
Conditions
Brief summary
The study aims to evaluate the current methods of surgical treatment for Congenital Pseudarthrosis of tibia(CPT) in children and their results respectively.
Detailed description
The study aims to evaluate the current surgical treatment and its result for Congenital Pseudarthrosis of tibia (CPT)in children in China. A retrospective study will be conducted with around 150 patients at 11 centers in China. This study will use available registry data from a defined time period of Jan 2006-Dec 2014. The treatment method will be recorded. The bone union rate and the refracture rate were calculated to evaluate the final result of several surgical treatment.
Interventions
None listed
Sponsors
Guangzhou Women and Children's Medical Center
Shenzhen Children's Hospital
Tongji Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan Women and Children's Medical Center
Foshan Hospital of Traditional Chinese Medicine
Beijing Children's Hospital
Dalian Children's Hospital
Children's Hospital of Chongqing Medical University
Kunming Children's Hospital
Hunan Children's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
The inclusion criteria consists of patients with congenital pseudarthrosis of Tibia who were surgical treated to obtain bone union.
Exclusion criteria
* Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or significant barriers to growth. * Patients with pseudarthrosis of tibia caused by trauma, tumor,infection, etc * Children are complicated with dysfunction of liver and kidney , blood disorders, immune deficiency disease and ECG abnormalities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| whether the tibial has obtained union | 9 months post-operation | Ohnishi criterion: Degree of union was evaluated by the findings on radiographs and classified into three grades( Ohnishi criterion): union, delayed union, and nonunion. Radiographic union was defined as possessing continuity of bone density between the fragments without obvious radiolucent zone between them and possessing cortex-bridging fragments with sufficient thickness and radiodensity on both anteroposterior and lateral radiographs. Delayed union was defined as a process of healing that was slow but was progressing. Nonunion was defined by the healing process that had completely ceased. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical outcome measurement(Johnston clinical evaluation criterion) | 9 months post-operation，the last follow up | Johnston clinical evaluation criterion of Congenital Pseudarthrosis of Tibia (CPT): The outcome was classified as grade 1 when there was unequivocal union with full weight-bearing function and maintenance of alignment requiring no additional surgical treatment; grade 2 when there was equivocal union with useful function, with the limb protected by a brace, and/or valgus or sagittal bowing for which additional surgery was required or anticipated; and grade 3 when there was persistent nonunion or refracture, requiring full-time external support for pain and/or instability. |
| Refracture of tibia | Time Frame: 1,2,3,4,5,6,7,8,9 years post-operation,the last follow-up | The continuity of tibia cortex was disappeared in X ray. |
Countries
China
Contacts
Primary ContactHaibo Mei
Backup ContactKewei Wang
Outcome results
None listed