A Retrospective Study of Surgical Treatment of Congenital Pseudarthrosis of Tibia in China

• Conditions: Congenital Pseudarthrosis of Tibia

• Registration Number: NCT02896114
• Lead Sponsor: Hunan Children's Hospital

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hunan Children's Hospital; 🇨🇳 Changsha, Hunan, China