Clinical Applications of a Joystick in Femoral Shaft Fractures

Femur Shaft Fracture Clinical Trial

Official title:

Studying the Clinical Applications of "H" Joystick for Reduction in Femoral Shaft Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417310
• Other study ID #: 2015030024
• Status: Completed
• Phase: N/A
• First received: January 24, 2018
• Last updated: January 24, 2018
• Start date: April 1, 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: January 2018
• Source: MGH Institute of Health Professions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Femur shaft fractures

Exclusion Criteria:

• Not suitable to receive intramedullary nail treatment

Related Conditions & MeSH terms

• Femur Shaft Fracture
• Fractures, Bone

Intervention

Device:
• "H" joystick
A joystick that corrects lateral displacement and angulation for multi-direction reduction

Procedure:
• Common reduction methods
Manual reduction methods without the assistance of any devices

Locations

Country	Name	City	State
China	Shenzhen People's Hospital	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
MGH Institute of Health Professions	Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operating time	Duration of operation	One day
Primary	Fluoroscopy times	The number of times for fluoroscopy	One day
Primary	Blood loss	The amount of blood loss	One day