Free Nonvascularized Fibula Autograft for Tumor-like Lesions in Femoral Neck Using in Pediatric Patients

Bone Diseases Clinical Trial

Official title:

Yulin Orthopedics Hospital of Chinese and Western Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129230
• Other study ID #: 20170301c
• Status: Completed
• Phase: N/A
• Start date: August 1, 2012
• Est. completion date: March 1, 2017

Study information

• Verified date: November 2018
• Source: Yulin Orthopedics Hospital of Chinese and Western Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was to evaluate the safety and efficacy of free nonvascularized fibula autograft in the treatment of the femoral neck tumor-like lesions before epiphyseal closure in pediatric patients, by presenting the clinic-radiological outcome and complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 1, 2017
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

Inclusion Criteria:

1. This retrospective study included pediatric patients before epiphyseal closure with tumor-like lesions in femoral neck.

Exclusion Criteria:

1. pediatric patients with tumor-like lesions in femoral neck after epiphyseal closure;

2. pediatric patients with benign bone tumors and malignant bone tumors in the femoral neck after epiphyseal closure;

3. adult patients with benign or malignant bone tumors and tumor-like lesions in femoral neck.

Related Conditions & MeSH terms

• Bone Diseases

Intervention

Procedure:
• free nonvascularized fibula autograft
Sixteen pediatric patients before epiphyseal closure were treated with free nonvascularized fibula autograft after resections of tumor-like lesions in the femoral neck between Aug. 2012 and Sep. 2016. All the patients were given supplementary skeletal traction through supracondyle of femur for 4 weeks to 6 weeks after the resections.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Yulin Orthopedics Hospital of Chinese and Western Medicine	Yulin	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Yulin Orthopedics Hospital of Chinese and Western Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of peri-implant bone level from baseline at 7 and 54 months	Mean follow-up of all the patients after primary surgery was 24 months, ranged 7 months to 54 months.	7 months to 54 months