Back to resultsClinical Applications of a Joystick in Femoral Shaft Fractures
Primary Purpose
Femur Shaft Fracture
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
"H" joystick
Common reduction methods
Sponsored by
About this trial
This is an interventional treatment trial for Femur Shaft Fracture focused on measuring closed reduction, locked intramedullary nailing
Eligibility Criteria
Inclusion Criteria:
- Femur shaft fractures
Exclusion Criteria:
- Not suitable to receive intramedullary nail treatment
Sites / Locations
- Shenzhen People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
"H" joystick
Common reduction methods
Arm Description
Patients are treated with the "H" joystick on a traction table
Patients are treated with common reduction methods on a traction table
Outcomes
Primary Outcome Measures
Operating time
Duration of operation
Fluoroscopy times
The number of times for fluoroscopy
Blood loss
The amount of blood loss
Secondary Outcome Measures
Full Information
NCT ID
NCT03417310
First Posted
January 24, 2018
Last Updated
January 24, 2018
Sponsor
MGH Institute of Health Professions
Collaborators
Shenzhen People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03417310
Brief Title
Clinical Applications of a Joystick in Femoral Shaft Fractures
Official Title
Studying the Clinical Applications of "H" Joystick for Reduction in Femoral Shaft Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MGH Institute of Health Professions
Collaborators
Shenzhen People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Shaft Fracture
Keywords
closed reduction, locked intramedullary nailing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"H" joystick
Arm Type
Experimental
Arm Description
Patients are treated with the "H" joystick on a traction table
Arm Title
Common reduction methods
Arm Type
Active Comparator
Arm Description
Patients are treated with common reduction methods on a traction table
Intervention Type
Device
Intervention Name(s)
"H" joystick
Intervention Description
A joystick that corrects lateral displacement and angulation for multi-direction reduction
Intervention Type
Procedure
Intervention Name(s)
Common reduction methods
Intervention Description
Manual reduction methods without the assistance of any devices
Primary Outcome Measure Information:
Title
Operating time
Description
Duration of operation
Time Frame
One day
Title
Fluoroscopy times
Description
The number of times for fluoroscopy
Time Frame
One day
Title
Blood loss
Description
The amount of blood loss
Time Frame
One day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Femur shaft fractures
Exclusion Criteria:
Not suitable to receive intramedullary nail treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinjia Hu, MD, PhD
Organizational Affiliation
Shenzhen People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Applications of a Joystick in Femoral Shaft Fractures
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