The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Hunan Children's Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- whether the tibial has obtained union.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
whether the tibial has obtained union.
Time Frame: 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 Outcomes
- clinical outcome measurement(Johnston clinical evaluation criterion)(3,6,9,12,18,24 months post-operation)
- Refracture of tibia(0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation)