Digital Three-dimensional Imaging Models for Repair of Complex Long Bone Fractures
1 other identifier
interventional
63
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 12, 2016
CompletedFirst Posted
Study publicly available on registry
November 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 9, 2018
February 1, 2018
1.3 years
November 12, 2016
February 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
X-ray examination
To evaluate total efficacy at postoperative 6 months
postoperative 6 months
Secondary Outcomes (2)
Harris scores
preoperatively and 6 months postoperatively
Visual Analogue Scale
preoperatively and 6 months postoperatively
Study Arms (2)
the observation group
EXPERIMENTAL32 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
EXPERIMENTAL31 patients will be randomized to undergo conventional internal fixation in the control group.
Interventions
In the observation group, digital three-dimensional models will be established by CT scan for internal fixation.
In the control group, patients will undergo conventional internal fixation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zichun Zhao, Master
Affiliated Hospital of Qinghai University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Chief Physician
Study Record Dates
First Submitted
November 12, 2016
First Posted
November 16, 2016
Study Start
December 1, 2014
Primary Completion
April 1, 2016
Study Completion
December 1, 2016
Last Updated
February 9, 2018
Record last verified: 2018-02