Femur Shaft FractureNCT03417310
Clinical Applications of a Joystick in Femoral Shaft Fractures
A study testing "H" joystick and Common reduction methods in people with Femur Shaft Fracture, run by MGH Institute of Health Professions at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Femur Shaft Fracture
- What is being tested?
- "H" joystick and Common reduction methods
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2015to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Femur shaft fractures
Who cannot join
- Not suitable to receive intramedullary nail treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Femur Shaft Fracture
- Being tested
- "H" joystick, Common reduction methods
- Keywords
- closed reduction, locked intramedullary nailing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"H" joystickDevice
A joystick that corrects lateral displacement and angulation for multi-direction reduction
Common reduction methodsProcedure or surgery
Manual reduction methods without the assistance of any devices
| Study group | Role | What they receive |
|---|---|---|
| "H" joystick | Experimental | Patients are treated with the "H" joystick on a traction table Receives: Device: "H" joystick |
| Common reduction methods | Active comparator | Patients are treated with common reduction methods on a traction table Receives: Procedure: Common reduction methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating time
Duration of operation
Measured: One day
Fluoroscopy times
The number of times for fluoroscopy
Measured: One day
Blood loss
The amount of blood loss
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start1 Apr 2015
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur Shaft FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- MGH Institute of Health Professions
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen People's Hospital
- Responsible party
- Principal investigator, John Wong, MGH Institute of Health Professions
- Investigators
- Xinjia Hu, MD, PhD, Principal investigator, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417310
- Sponsor's protocol ID
- 2015030024
- Status last verified
- Jan 2018
- First submitted
- 24 Jan 2018
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Clinical Applications of "H" Joystick for Reduction in Femoral Shaft Fractures
- ClinicalTrials.gov ID
- NCT03417310
- Acronym / sponsor ID
- 2015030024
- Conditions
- Femur Shaft Fracture
- Keywords
- closed reduction, locked intramedullary nailing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- MGH Institute of Health ProfessionsUniversity, hospital or other
- Collaborators
- Shenzhen People's Hospital
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "H" joystick | Experimental | Device: "H" joystickPatients are treated with the "H" joystick on a traction table |
| Common reduction methods | Active comparator | Procedure: Common reduction methodsPatients are treated with common reduction methods on a traction table |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Femur shaft fractures
Key exclusion criteria (1 listed)
- Not suitable to receive intramedullary nail treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "H" joystickA joystick that corrects lateral displacement and angulation for multi-direction reduction | Device | "H" joystick |
| Common reduction methodsManual reduction methods without the assistance of any devices | Procedure or surgery | Common reduction methods |
Primary outcome
Operating time
Time frame: One day
Duration of operation
Fluoroscopy times
Time frame: One day
The number of times for fluoroscopy
Blood loss
Time frame: One day
The amount of blood loss
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Femur Shaft Fracture
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Rehabilitation After Lower Extremity Nailing Trial
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Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft Fractures
Femoral Shaft Fractures, Femur Fractures
Not yet recruiting
Feasibility of Structured Resistance Training After Lower Extremity Fracture
Lower Extremity Fractures
Recruiting
Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures
Femoral Fracture
Recruiting
Assessing Bone Fracture Healing Effect of Almonds
Femur Shaft Fracture, Tibia Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinjia Hu, MD, PhD principal investigator
Shenzhen People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "H" joystick and Common reduction methods in people with Femur Shaft Fracture, run by MGH Institute of Health Professions at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operating time (time frame: One day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.