Back to resultsUse of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure
Primary Purpose
Bone Diseases
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
surgical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Bone Diseases focused on measuring radiopaque localizer grid, methylene blue, reduce radiation exposure
Eligibility Criteria
Inclusion Criteria:
- patients with lesions <20.0 mm
Exclusion Criteria:
- patients with lesions >20.0 mm
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
surgery group
Arm Description
The dissection was continued into the deeper layers until the bone lesion was visualized, and the bone lesion was then thoroughly resected.
Outcomes
Primary Outcome Measures
The times of C-arm fluoroscopy used
Secondary Outcome Measures
incision length
Full Information
NCT ID
NCT02969005
First Posted
October 24, 2016
Last Updated
November 23, 2016
Sponsor
Children's Hospital of Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02969005
Brief Title
Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure
Official Title
Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure in Resection Small Femur Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Chongqing Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Localization of small femur lesions for resection can be challenging and may be associated with the need for significant fluoroscopic imaging and tissue dissection.
Detailed Description
This study was performed to evaluate the use of a radiopaque localizer grid along with methylene blue staining for resection of small femur lesions in children, and to determine this technique's effectiveness at reducing radiation exposure and tissue injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Diseases
Keywords
radiopaque localizer grid, methylene blue, reduce radiation exposure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
surgery group
Arm Type
Experimental
Arm Description
The dissection was continued into the deeper layers until the bone lesion was visualized, and the bone lesion was then thoroughly resected.
Intervention Type
Radiation
Intervention Name(s)
surgical treatment
Intervention Description
Use of a radiopaque localizer grid and methylene blue staining as an aid to resect the lesions
Primary Outcome Measure Information:
Title
The times of C-arm fluoroscopy used
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
incision length
Time Frame
intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with lesions <20.0 mm
Exclusion Criteria:
patients with lesions >20.0 mm
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure
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