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

NCT ID: NCT02856828

Last Updated: 2019-10-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-02-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Radiation Exposure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Digital Image Enhancement (DIE) Group

A novel digital image enhancement technology will be used intraoperatively

Group Type EXPERIMENTAL

DIE

Intervention Type DEVICE

digital image enhancement

Control Group

Standard intraoperative imaging will be used intraoperatively

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DIE

digital image enhancement

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* closed hip fracture requiring intramedullary nailing

Exclusion Criteria

* age \<18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke University

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00074745

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

FDG-PET Imaging in Painful Joint Prosthesis
NCT00194285 ACTIVE_NOT_RECRUITING
Evaluating Femoral Traction
NCT06160804 TERMINATED NA
HIP: Hip Imaging Protocol
NCT04126161 SUSPENDED NA
Image Guided System for Orthopaedic Surgery
NCT00022802 TERMINATED PHASE2