Clinical Applications of a Joystick in Femoral Shaft Fractures

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

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.

Study Overview

• Status: Completed
• Conditions: Femur Shaft Fracture
• Intervention / Treatment: Device: "H" joystick; Procedure: Common reduction methods

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Shenzhen People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Femur shaft fractures

Exclusion Criteria:

• Not suitable to receive intramedullary nail treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "H" joystick; Patients are treated with the "H" joystick on a traction table	Device: "H" joystick; A joystick that corrects lateral displacement and angulation for multi-direction reduction
Active Comparator: Common reduction methods; Patients are treated with common reduction methods on a traction table	Procedure: Common reduction methods; Manual reduction methods without the assistance of any devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: MGH Institute of Health Professions
• Collaborators: Shenzhen People's Hospital
• Investigators: Principal Investigator: Xinjia Hu, MD, PhD, Shenzhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: closed reduction; locked intramedullary nailing
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 2015030024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No