Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures

Not Applicable

Terminated

• Conditions: Radiation Exposure
• Interventions: Device: DIE

• Registration Number: NCT02856828
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to evaluate the effectiveness of a novel digital image enhancement (DIE) technology in reducing the radiation exposure to both the patient and surgical staff during standard intramedullary nail placement for treatment of hip fractures. Secondarily, to evaluate whether the image quality and reproducibility of desired images can be improved with use of the DIE technology. Finally, to evaluate whether DIE technology reduces total operative time.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Study Start: 2017-03-01
• Primary Completion: 2018-02-06
• Study Completion: 2018-02-06
• Disposition First Submitted: 2019-04-05
• Disposition First Submitted QC: 2019-04-05
• Disposition First Posted: 2019-04-17
• Results First Submitted: 2019-09-12
• Results First Submitted QC: 2019-09-12
• Status Verified: 2019-10
• Results First Posted: 2019-10-01
• Last Update Submitted: 2019-10-04
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• closed hip fracture requiring intramedullary nailing

Exclusion Criteria

• age <18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Image Enhancement (DIE) Group	DIE	A novel digital image enhancement technology will be used intraoperatively

Primary Outcome Measures

Name	Time	Method
Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge	intraoperatively
Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge	intraoperatively
Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge	intraoperatively

Secondary Outcome Measures

Name	Time	Method
Image Quality and Reproducibility of Desired Images	intraoperatively	Measured by questionnaire related to image quality. Quality scale of 1-10, 1 being poor image quality and 10 being excellent image quality.
Operative Time	intraoperatively

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States