Clinical Applications of a Joystick in Femoral Shaft Frac... | NCT03417310

Studies
Clinical Applications of a Joystick in Femoral Shaft Fractures

NCT03417310

Sponsor

MGH Institute of Health Professions

Status

Completed

Last Update Posted

Jan 31, 2018Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Femur Shaft Fracture

Interventions

"H" joystick
Common reduction methods

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2015Actual

Primary Completion Date

Mar 31, 2017Actual

Completion Date

Mar 31, 2017Actual

First Submitted Date

Jan 24, 2018

First Submission Date that Met QC Criteria

Jan 24, 2018

First Posted Date

Jan 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2018

Last Update Posted Date

Jan 31, 2018Actual

Name	Class
Shenzhen People's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
"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

Name	Type	Description	Arm Group Labels	Other Names
"H" joystick	Device	A joystick that corrects lateral displacement and angulation for multi-direction reduction	"H" joystick

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Femur shaft fractures

Exclusion Criteria:

Not suitable to receive intramedullary nail treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xinjia Hu, MD, PhD	Shenzhen People's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shenzhen People's Hospital		Shenzhen	Guangdong	518000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided