Back to resultsFree Nonvascularized Fibula Autograft for Tumor-like Lesions in Femoral Neck Using in Pediatric Patients
Primary Purpose
Bone Diseases
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
free nonvascularized fibula autograft
Sponsored by
About this trial
This is an interventional treatment trial for Bone Diseases
Eligibility Criteria
Inclusion Criteria:
1. This retrospective study included pediatric patients before epiphyseal closure with tumor-like lesions in femoral neck.
Exclusion Criteria:
- pediatric patients with tumor-like lesions in femoral neck after epiphyseal closure;
- pediatric patients with benign bone tumors and malignant bone tumors in the femoral neck after epiphyseal closure;
- adult patients with benign or malignant bone tumors and tumor-like lesions in femoral neck.
Sites / Locations
- The First Affiliated Hospital of Guangxi Medical University
- Yulin Orthopedics Hospital of Chinese and Western Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Free nonvascularized fibula autograft
Arm Description
Sixteen pediatric patients before epiphyseal closure were treated with free nonvascularized fibula autograft after resections of tumor-like lesions in the femoral neck.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03129230
First Posted
April 5, 2017
Last Updated
November 25, 2018
Sponsor
Yulin Orthopedics Hospital of Chinese and Western Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03129230
Brief Title
Free Nonvascularized Fibula Autograft for Tumor-like Lesions in Femoral Neck Using in Pediatric Patients
Official Title
Yulin Orthopedics Hospital of Chinese and Western Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2012 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
March 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yulin Orthopedics Hospital of Chinese and Western Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Free nonvascularized fibula autograft
Arm Type
Experimental
Arm Description
Sixteen pediatric patients before epiphyseal closure were treated with free nonvascularized fibula autograft after resections of tumor-like lesions in the femoral neck.
Intervention Type
Procedure
Intervention Name(s)
free nonvascularized fibula autograft
Intervention Description
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.
Primary Outcome Measure Information:
Title
change of peri-implant bone level from baseline at 7 and 54 months
Description
Mean follow-up of all the patients after primary surgery was 24 months, ranged 7 months to 54 months.
Time Frame
7 months to 54 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. This retrospective study included pediatric patients before epiphyseal closure with tumor-like lesions in femoral neck.
Exclusion Criteria:
pediatric patients with tumor-like lesions in femoral neck after epiphyseal closure;
pediatric patients with benign bone tumors and malignant bone tumors in the femoral neck after epiphyseal closure;
adult patients with benign or malignant bone tumors and tumor-like lesions in femoral neck.
Facility Information:
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Yulin Orthopedics Hospital of Chinese and Western Medicine
City
Yulin
State/Province
Guangxi
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Free Nonvascularized Fibula Autograft for Tumor-like Lesions in Femoral Neck Using in Pediatric Patients
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