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

October 20, 2020 updated by: Hunan Children's Hospital
The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410007
        • Recruiting
        • Hunan Children's Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: combined 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.
Device: llizarov external fixation device
llizarov external fixation device was applied to fix the tibia.
Other Names:
  • llizarov fixator
Device: intramedullary rod fixation
retrograde intramedullary rod was applied to stabilize the tibia.
Other Names:
  • intramedullary rodding
Procedure: surgery
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.
Other Names:
  • combined surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical outcome measurement(Johnston clinical evaluation criterion)
Time Frame: 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.
3,6,9,12,18,24 months post-operation
Refracture of tibia
Time Frame: 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.
0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual Deformity-proximal tibia angulation(range,0°-90°)
Time Frame: 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
pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Residual Deformity-Limb length discrepancy
Time Frame: 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
pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Residual Deformity-ankle valgus angulation(range,0°-90°)
Time Frame: 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.
pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunan Children's Hospital

Collaborators

Tongji Hospital
Wuhan Union Hospital, China
Beijing Children's Hospital
Kunming Children's Hospital
Guangzhou Women and Children's Medical Center
Shenzhen Children's Hospital
Children's Hospital of Chongqing Medical University
Wuhan Women and Children's Medical Center
Foshan Hospital of Traditional Chinese Medicine
Dalian Children's Hospital

Investigators

  • Principal Investigator: Xu Yao, Hunan Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimate)

December 28, 2015

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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