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

• Sponsor: Yulin Orthopedics Hospital of Chinese and Western Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT03129230
• Collaborator: (none)
• Enrollment: 16
• Locations: 2
• Arm: 1
• Actual Duration (Months): 55
• Patients Per Site: 8
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Diseases	Procedure: free nonvascularized fibula autograft	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Yulin Orthopedics Hospital of Chinese and Western Medicine
• Actual Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. change of peri-implant bone level from baseline at 7 and 54 months [7 months to 54 months]

   Mean follow-up of all the patients after primary surgery was 24 months, ranged 7 months to 54 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 13 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi	China	530021
2	Yulin Orthopedics Hospital of Chinese and Western Medicine	Yulin	Guangxi	China

Sponsors and Collaborators

• Yulin Orthopedics Hospital of Chinese and Western Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanchao Luo, Director, Yulin Orthopedics Hospital of Chinese and Western Medicine
• ClinicalTrials.gov Identifier: NCT03129230
• Other Study ID Numbers: 20170301c
• First Posted: Apr 26, 2017
• Last Update Posted: Nov 27, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bone Diseases

Study Results

No Results Posted as of Nov 27, 2018