Bone FractureNCT02964754
Digital Three-dimensional Imaging Models for Repair of Complex Long Bone Fractures
A study testing CT scan for internal fixation and conventional internal fixation in people with Bone Fracture, run by Qinghai University.
Trial summary
To verify whether digital three-dimensional model-assisted internal fixation can obtain better effects in the repair of complex long bone fractures compared with conventional internal fixation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Fracture
- What is being tested?
- CT scan for internal fixation and conventional internal fixation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Long bone fractures in the four limbs, such as middle segment of humerus, femur, ulna, radius, tibia and fibula; fractures are not related to the articular surface
- Diagnosed with complex long bone fractures via X-ray
- Admission within 6 hours after injury
Who cannot join
- Pathological fractures with vascular and nerve injuries
- Split fractures of the humeral head
- Neer IV fractures
- Humeral head compression area greater than 40%
- Glenohumeral dislocation
- Conscious disturbance, cerebral infarction, tumor, serious medical complications, such as heart, lung, kidney failure, severe hypertension, diabetes and blood diseases
- History of elbow joint dysfunction or shoulder joint disease
- Unwilling to sign the informed consent
About this study
Official title: Digital Three-dimensional Imaging Models for Repair of Complex Long Bone Fractures: a Randomized Controlled Trial With 6-month Follow-up
To verify whether digital three-dimensional model-assisted internal fixation can obtain better effects in the repair of complex long bone fractures compared with conventional internal fixation.
Read the detailed description
History and current related studies The internal fixator is difficult to completely fit the bone surface at the site of complex long bone fracture, which reduces the firmness of fixation. From a safety point of view, the establishment of a digital three-dimensional measurement model is undoubtedly a very reliable and intuitive way. Digital three-dimensional models are established after CT scan, and these models can greatly reflect the site and degree of fractures, and reduce anatomical parameters, with high degree of simulation and feasibility.
Adverse events
- The investigators will record adverse events, including screw loosening and falling off, steel plate fracture and bending, joint stiffness, delayed healing or non-healing, peripheral nerve injury and infection.
- If severe adverse events occur, investigators will report details, including the date of occurrence and measures taken to treat the adverse events, to the principle investigator and the institutional review board within 24 hours.
Data collection, management, analysis and open-access
- Data collection: Case report forms with demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse events will be collected, processed using Epidata software (Epidata Association, Odense, Denmark), collated, and then recorded electronically by data managers using a double-data entry strategy.
- Data management: The locked electronic database will be accessible and locked only by the project manager, and will not be altered. All data regarding this trial will be preserved by the Affiliated Hospital of Qinghai University, China.
- Data analysis: The electronic database will be statistically analyzed by a professional statistician who will create an outcome analysis report that will be submitted to the lead researchers. An independent data monitoring committee will supervise and manage the trial data, ensuring a scientific and stringent trial to yield accurate and complete data.
- Data open access: Anonymized trial data will be published at www.figshare.com.
Statistical analysis
- Statistical analysis will be performed using SPSS 19.0 software, and will follow the intention-to-treat principle. Normally distributed measurement data will be expressed as mean ± standard deviation, and minimums and maximums. Non-normally distributed measurement data will be expressed as lower quartile (q1), and median and upper quartile (q3).
- Fisher's exact test will be performed for comparison of total efficacy and the incidence of adverse reactions preoperatively and 6 months postoperatively. Mann Whitney U test will be used to compare Harris score, Visual Analogue Scale, operation time and hospital stay between the two groups. The significance level will be α = 0.05.
- Conditions
- Bone Fracture
- Being tested
- CT scan for internal fixation, conventional internal fixation
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scan for internal fixationDevice
In the observation group, digital three-dimensional models will be established by CT scan for internal fixation.
conventional internal fixationProcedure or surgery
In the control group, patients will undergo conventional internal fixation.
| Study group | Role | What they receive |
|---|---|---|
| the observation group | Experimental | 32 patients with complex long bone fractures will be randomized to undergo digital three-dimensional models will be established by CT scan for internal fixation in the observation group. Receives: Device: CT scan for internal fixation |
| the control group | Experimental | 31 patients will be randomized to undergo conventional internal fixation in the control group. Receives: Procedure: conventional internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
X-ray examination
To evaluate total efficacy at postoperative 6 months
Measured: postoperative 6 months
Secondary outcomes (2)
Harris scores
To assesse the recovery of hip function
Measured: preoperatively and 6 months postoperatively
Visual Analogue Scale
To evaluate the pain, and the high score represents severe pain.
Measured: preoperatively and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startDec 2014
- Primary completionApr 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qinghai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zichun Zhao, Qinghai University
- Investigators
- Zichun Zhao, Master, Principal investigator, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964754
- Sponsor's protocol ID
- QinghaiUH_006
- Status last verified
- Feb 2018
- First submitted
- 12 Nov 2016
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Three-dimensional Imaging Models for Repair of Complex Long Bone Fractures: a Randomized Controlled Trial With 6-month Follow-up
- ClinicalTrials.gov ID
- NCT02964754
- Acronym / sponsor ID
- QinghaiUH_006
- Conditions
- Bone Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Qinghai UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Nov 2016 (estimated)
- 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.
To verify whether digital three-dimensional model-assisted internal fixation can obtain better effects in the repair of complex long bone fractures compared with conventional internal fixation.
Detailed description
History and current related studies The internal fixator is difficult to completely fit the bone surface at the site of complex long bone fracture, which reduces the firmness of fixation. From a safety point of view, the establishment of a digital three-dimensional measurement model is undoubtedly a very reliable and intuitive way. Digital three-dimensional models are established after CT scan, and these models can greatly reflect the site and degree of fractures, and reduce anatomical parameters, with high degree of simulation and feasibility.
Adverse events
- The investigators will record adverse events, including screw loosening and falling off, steel plate fracture and bending, joint stiffness, delayed healing or non-healing, peripheral nerve injury and infection.
- If severe adverse events occur, investigators will report details, including the date of occurrence and measures taken to treat the adverse events, to the principle investigator and the institutional review board within 24 hours.
Data collection, management, analysis and open-access
- Data collection: Case report forms with demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse events will be collected, processed using Epidata software (Epidata Association, Odense, Denmark), collated, and then recorded electronically by data managers using a double-data entry strategy.
- Data management: The locked electronic database will be accessible and locked only by the project manager, and will not be altered. All data regarding this trial will be preserved by the Affiliated Hospital of Qinghai University, China.
- Data analysis: The electronic database will be statistically analyzed by a professional statistician who will create an outcome analysis report that will be submitted to the lead researchers. An independent data monitoring committee will supervise and manage the trial data, ensuring a scientific and stringent trial to yield accurate and complete data.
- Data open access: Anonymized trial data will be published at www.figshare.com.
Statistical analysis
- Statistical analysis will be performed using SPSS 19.0 software, and will follow the intention-to-treat principle. Normally distributed measurement data will be expressed as mean ± standard deviation, and minimums and maximums. Non-normally distributed measurement data will be expressed as lower quartile (q1), and median and upper quartile (q3).
- Fisher's exact test will be performed for comparison of total efficacy and the incidence of adverse reactions preoperatively and 6 months postoperatively. Mann Whitney U test will be used to compare Harris score, Visual Analogue Scale, operation time and hospital stay between the two groups. The significance level will be α = 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the observation group | Experimental | Device: CT scan for internal fixation32 patients with complex long bone fractures will be randomized to undergo digital three-dimensional models will be established by CT scan for internal fixation in the observation group. |
| the control group | Experimental | Procedure: conventional internal fixation31 patients will be randomized to undergo conventional internal fixation in the control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Long bone fractures in the four limbs, such as middle segment of humerus, femur, ulna, radius, tibia and fibula; fractures are not related to the articular surface
- Diagnosed with complex long bone fractures via X-ray
- Admission within 6 hours after injury
Key exclusion criteria (8 listed)
- Pathological fractures with vascular and nerve injuries
- Split fractures of the humeral head
- Neer IV fractures
- Humeral head compression area greater than 40%
- Glenohumeral dislocation
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 |
|---|---|---|
| CT scan for internal fixationIn the observation group, digital three-dimensional models will be established by CT scan for internal fixation. | Device | the observation group |
| conventional internal fixationIn the control group, patients will undergo conventional internal fixation. | Procedure or surgery | the control group |
Primary outcome
X-ray examination
Time frame: postoperative 6 months
To evaluate total efficacy at postoperative 6 months
2 secondary outcomes
Harris scores
Time frame: preoperatively and 6 months postoperatively
Visual Analogue Scale
Time frame: preoperatively and 6 months postoperatively
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 9 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Zichun Zhao, Master principal investigator
Affiliated Hospital of Qinghai University
Questions about this trial
What is this clinical trial studying?
A study testing CT scan for internal fixation and conventional internal fixation in people with Bone Fracture, run by Qinghai University.
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 3 inclusion and 8 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 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
X-ray examination (time frame: postoperative 6 months). 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 9 Feb 2018.