Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure

Bone Diseases Clinical Trial

Official title:

Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure in Resection Small Femur Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969005
• Other study ID #: ChongqingMUCH
• Status: Completed
• Phase: N/A
• First received: October 24, 2016
• Last updated: November 23, 2016
• Start date: January 2010
• Est. completion date: January 2015

Study information

• Verified date: November 2016
• Source: Children's Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Chongqing City
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 9 Years

Eligibility

Inclusion Criteria:

• patients with lesions <20.0 mm

Exclusion Criteria:

• patients with lesions >20.0 mm

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Diseases

Intervention

Radiation:
• surgical treatment
Use of a radiopaque localizer grid and methylene blue staining as an aid to resect the lesions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Chongqing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The times of C-arm fluoroscopy used		intraoperative	Yes
Secondary	incision length		intraoperative	Yes