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

Yulin Orthopedics Hospital of Chinese and Western Medicine

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.

Study Overview

• Status: Completed
• Conditions: Bone Diseases
• Intervention / Treatment: Procedure: free nonvascularized fibula autograft

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
    • Yulin, Guangxi, China
      • Yulin Orthopedics Hospital of Chinese and Western Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yulin Orthopedics Hospital of Chinese and Western Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 22, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 25, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases
• Other Study ID Numbers: 20170301c

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No