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

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

NCT02640040

HN02

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