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

Not Applicable

Recruiting

• Conditions: Congenital Pseudarthrosis of Tibia
• Interventions: Device: llizarov external fixation device; Device: intramedullary rod fixation; Procedure: surgery

• Registration Number: NCT02640040
• Lead Sponsor: Hunan Children's Hospital

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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-28
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
combined surgery	llizarov external fixation device	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.
combined surgery	surgery	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.
combined surgery	intramedullary rod fixation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

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