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

H

Hunan Children's Hospital

Status

Enrolling

Conditions

Congenital Pseudarthrosis of Tibia

Treatments

Device: llizarov external fixation device
Device: intramedullary rod fixation
Procedure: surgery

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

combined surgery
Experimental group
Description:
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.
Treatment:
Procedure: surgery
Device: intramedullary rod fixation
Device: llizarov external fixation device

Trial contacts and locations

1

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Central trial contact

Kewei Wang, M.D; Haibo Mei, M.D.

Data sourced from clinicaltrials.gov

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