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Clinical Applications of a Joystick in Femoral Shaft Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417310
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
Shenzhen People's Hospital
Information provided by (Responsible Party):
John Wong, MGH Institute of Health Professions

Study Description
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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.

Condition or disease Intervention/treatment Phase
Femur Shaft Fracture Device: "H" joystick Procedure: Common reduction methods Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Studying the Clinical Applications of "H" Joystick for Reduction in Femoral Shaft Fractures
Actual Study Start Date : April 1, 2015
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Operating time [ Time Frame: One day ]
    Duration of operation

  2. Fluoroscopy times [ Time Frame: One day ]
    The number of times for fluoroscopy

  3. Blood loss [ Time Frame: One day ]
    The amount of blood loss


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Femur shaft fractures

Exclusion Criteria:

  • Not suitable to receive intramedullary nail treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417310


Locations
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China, Guangdong
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518000
Sponsors and Collaborators
MGH Institute of Health Professions
Shenzhen People's Hospital
Investigators
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Principal Investigator: Xinjia Hu, MD, PhD Shenzhen People's Hospital
More Information
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Responsible Party: John Wong, Assistant Professor, MGH Institute of Health Professions
ClinicalTrials.gov Identifier: NCT03417310    
Other Study ID Numbers: 2015030024
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Wong, MGH Institute of Health Professions:
closed reduction
locked intramedullary nailing
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries