MedDataX Logo

Clinical Applications of a Joystick in Femoral Shaft Fractures

NCT ID: NCT03417310

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-01

Study Completion Date

2017-03-31

Brief Summary

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

This study will use a new "H" joystick for reduction on patients with femur fractures to investigate the reduction time, operating time and bone healing status for the evaluation of the clinical application benefits of this joystick.

Detailed Description

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

This study will design a new "H" joystick for reduction (which has received the national utility model patent) and will use this equipment on 80 patients (55 males, 25 females) with femur fractures to investigate the reduction time, operating time and bone healing status for the evaluation of the clinical application benefits of this joystick.

Conditions

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

Femur Shaft Fracture

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

closed reduction locked intramedullary nailing

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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

"H" joystick

Patients are treated with the "H" joystick on a traction table

Group Type EXPERIMENTAL

"H" joystick

Intervention Type DEVICE

A joystick that corrects lateral displacement and angulation for multi-direction reduction

Common reduction methods

Patients are treated with common reduction methods on a traction table

Group Type ACTIVE_COMPARATOR

Common reduction methods

Intervention Type PROCEDURE

Manual reduction methods without the assistance of any devices

Interventions

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

"H" joystick

A joystick that corrects lateral displacement and angulation for multi-direction reduction

Intervention Type DEVICE

Common reduction methods

Manual reduction methods without the assistance of any devices

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Femur shaft fractures

Exclusion Criteria

* Not suitable to receive intramedullary nail treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Shenzhen People's Hospital

OTHER

Sponsor Role collaborator

MGH Institute of Health Professions

OTHER

Sponsor Role lead

Responsible Party

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

John Wong

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xinjia Hu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shenzhen People's Hospital

Locations

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

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Site Status

Countries

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

China

Other Identifiers

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

2015030024

Identifier Type: -

Identifier Source: org_study_id