Combined surgery for congenital pseudarthrosis of the tibia
The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
This study is testing a new combined surgery approach for children with congenital pseudarthrosis of the tibia to see if it helps their bones heal better and faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Hunan Children's Hospital Government |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT02640040 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical outcomes of combined surgical techniques for managing congenital pseudarthrosis of the tibia. The approach includes sleeve resection of pathological soft tissues, retrograde intramedullary rodding, and the application of an Ilizarov external fixation device, along with packaged iliac bone autograft. Key metrics such as bone union rate, average healing time, healing index, ankle valgus, limb length discrepancy, and tibia axis alignment will be recorded and analyzed to assess the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with congenital pseudarthrosis of the tibia.
Not a fit: Patients with pseudarthrosis due to trauma, tumors, infections, or those with significant mental or neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve healing outcomes and functional mobility for patients with congenital pseudarthrosis of the tibia.
How similar studies have performed: While there is limited data on the specific combination of techniques used in this study, similar surgical approaches have shown promise in managing congenital pseudarthrosis in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Changsha, Hunan
- Hunan Children's Hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Principal investigator: Xu Yao — Hunan Children's Hospital
- Study coordinator: Haibo Mei, M.D.
- Email: meihaibo8@163.com
- Phone: 008613975197731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.