Free Nonvascularized Fibula Autograft for Tumor-like Lesions in Femoral Neck Using in Pediatric Patients
Yulin Orthopedics Hospital of Chinese and Western Medicine
1 other identifier
interventional
16
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 5, 2017
CompletedFirst Posted
Study publicly available on registry
April 26, 2017
CompletedNovember 27, 2018
November 1, 2018
4.1 years
April 5, 2017
November 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Free nonvascularized fibula autograft
EXPERIMENTALSixteen pediatric patients before epiphyseal closure were treated with free nonvascularized fibula autograft after resections of tumor-like lesions in the femoral neck.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \. This retrospective study included pediatric patients before epiphyseal closure with tumor-like lesions in femoral neck.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Yulin Orthopedics Hospital of Chinese and Western Medicine
Yulin, Guangxi, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
April 5, 2017
First Posted
April 26, 2017
Study Start
August 1, 2012
Primary Completion
September 1, 2016
Study Completion
March 1, 2017
Last Updated
November 27, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share