The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia

Study Overview
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Brief Summary
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The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis.

Detailed Description
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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.

Official Title
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The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia

Conditions
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Congenital Pseudarthrosis of Tibia

Intervention / Treatment
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* Device: llizarov external fixation device
* Device: intramedullary rod fixation
* Procedure: surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combined surgery<br>combined surgery for enrolled patients with CPT(Congenital Pseudarthrosis of Tibia): sleeve resection of the pathological soft tissues, intramedullary rod fixation, packaged lilac bone autograft,and llizarov external fixation device installation. | Device: llizarov external fixation device<br>* llizarov external fixation device was applied to fix the tibia.<br>* Other names: llizarov fixator;Device: intramedullary rod fixation<br>* retrograde intramedullary rod was applied to stabilize the tibia.<br>* Other names: intramedullary rodding;Procedure: surgery<br>* 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.<br>* Other names: combined surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whether the tibial has obtained union. | 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. | 6 months post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical outcome measurement(Johnston clinical evaluation criterion) | 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. | 3,6,9,12,18,24 months post-operation | 
| Refracture of tibia | The continuity of tibia cortex was disappeared in X ray. | 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation |