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

Duke University

Status: Terminated

Conditions: Radiation Exposure

Treatments: Device: DIE

Study type: Interventional

Funder types: Other

Identifiers

NCT02856828

Pro00074745

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• closed hip fracture requiring intramedullary nailing

Exclusion criteria

• age <18 years

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Digital Image Enhancement (DIE) Group

Experimental group

Description:

A novel digital image enhancement technology will be used intraoperatively

Treatment:

Device: DIE

Control Group

No Intervention group

Description:

Standard intraoperative imaging will be used intraoperatively