Congenital Pseudarthrosis of Tibia
Conditions
Brief summary
The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis.
Detailed description
The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis. The combined surgery includes sleeve resection of the pathological soft tissues, retrograde intramedullary rodding, packaged lilac bone autograft,and appliance of llizarov external fixation device. Bone uion rate,average time of healing, Healing index, ankle valgus, limb length discrepancy, tibia axis alignment are recorded and evaluated.
Interventions
DEVICEllizarov external fixation device
llizarov external fixation device was applied to fix the tibia.
DEVICEintramedullary rod fixation
retrograde intramedullary rod was applied to stabilize the tibia.
PROCEDUREsurgery
combined surgery for enrolled patients with CPT: sleeve resection of the pathological soft tissues, retrograde intramedullary rodding, packaged lilac bone autograft,and llizarov external fixation device installation.
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
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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
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. * Parents refused further treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| whether the tibial has obtained union. | 6 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) | 3,6,9,12,18,24 months post-operation | 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 | 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation | The continuity of tibia cortex was disappeared in X ray. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | measurement of the angulation of proximal tibia in anterior and posterior (AP )and lateral X ray |
| Residual Deformity-Limb length discrepancy | pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation | measurement of the length difference of both tibia in AP and lateral X ray |
| 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 | measurement of the angulation between the distal tibia and ankle joint. |
Countries
China
Contacts
Primary ContactHaibo Mei, M.D.
Backup ContactKewei Wang, M.D
Outcome results
None listed