NCT03417310

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

January 24, 2018

Last Update Submit

January 24, 2018

Conditions

Femur Shaft Fracture

Keywords

closed reductionlocked intramedullary nailing

Outcome Measures

Primary Outcomes (3)

  • Operating time

    Duration of operation

    One day

  • Fluoroscopy times

    The number of times for fluoroscopy

    One day

  • Blood loss

    The amount of blood loss

    One day

Study Arms (2)

"H" joystick

EXPERIMENTAL

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

Device: "H" joystick

Common reduction methods

ACTIVE COMPARATOR

Patients are treated with common reduction methods on a traction table

Procedure: Common reduction methods

Interventions

"H" joystickDEVICE

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

"H" joystick
Common reduction methodsPROCEDURE

Manual reduction methods without the assistance of any devices

Common reduction methods

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Femur shaft fractures

You may not qualify if:

  • Not suitable to receive intramedullary nail treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518000, China

Location

Study Officials

  • Xinjia Hu, MD, PhD

    Shenzhen People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 24, 2018

First Posted

January 31, 2018

Study Start

April 1, 2015

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

January 31, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)