Plain English Summary
Background and study aims
Pelvic fractures, especially the unstable pelvic fractures, are associated with massive hemorrhage or important organ injuries resulting in significant morbidity (disease) and mortality (death). The early reduction (a type of surgical procedure to try and fix the fracture) for the unstable pelvic fractures has been considered to be effective to improve the clinical results. However, the optimal early reduction technique for the unstable pelvic fractures remains controversial. This study uses a computer aided system to help treat the unstable fracture. The aim of this study is to verify the effectiveness and report early experience with reduction of the unstable pelvic fractures using a computer aided pelvic reduction frame.
Who can participate?
Adults aged 18 and older who have unilateral unstable pelvic fractures and displacements.
What does the study involve?
Participants undergo surgery for their unstable pelvic fracture using a computer aided reduction frame. Participants also undergo a CT scan (a type of imaging that uses x-rays to create a detailed image of the body) during the procedure to see the reduction quality. Based on this scan, a pelvic model is reconstructed and the differences between the model and the actual pelvis are calculated. The reduction precision of the fracture is measured and any complications are recorded.
What are the possible benefits and risks of participating?
The direct benefit for the patients taking part in the study include low complications rates, smaller incisions of the operations, and shorter rehabilitation period. The direct risks for the patients include higher radiation exposure from intraoperative CT scan.
Where is the study run from?
Chinese PLA General Hospital (China)
When is the study starting and how long is it expected to run for?
January 2014 to February 2018
Who is funding the study?
Chinese PLA General Hospital (China)
Who is the main contact?
1. Professor Pei-Fu Tang (Scientific)
2. Dr Jing-Xin Zhao (Scientific)
Trial website
Contact information
Type
Scientific
Primary contact
Prof Pei-Fu Tang
ORCID ID
Contact details
Department of Orthopaedics
Chinese PLA General Hospital
28 Fuxing Road
Haidian District
Beijing
100853
China
Type
Scientific
Additional contact
Dr Jing-Xin Zhao
ORCID ID
Contact details
Department of Orthopaedics
Chinese PLA General Hospital
28 Fuxing Road
Haidian District
Beijing
100853
China
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Early experience with reduction of unstable pelvic fracture using a computer aided reduction frame
Acronym
Study hypothesis
The aim of this study is to verify the effectiveness and report early experience with reduction of the unstable pelvic fractures using a computer aided pelvic reduction frame.
Ethics approval
Institutional Ethical Review Committee of Chinese PLA General Hospital, 01/01/2015
Study design
Prospective single-center single-group interventional study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Unstable pelvic fracture
Intervention
This study is a prospective single-group interventional study. All the participants in this study are allocated to the treatment group. All participants undergo the surgery of unstable pelvic fracture using a computer aided reduction frame.
For evaluation of the reduction quality of the clinical application of the entire system, this series of patients are performed with a second intro-operative CT scan after reduction with the frame. Based on this second intro-operative CT scan data, the 3D pelvic model at the anatomical reduction position can be reconstructed. The residual translational and rotational differences between the actual and virtual anatomical reduction positions could be calculated. The operation time is also recorded for the quality control of this technique.
Participants receive the standard post surgical care.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
1. The reduction precision of the unstable pelvic fractures is measured using the residual translational and rotational differences between the actual and virtual anatomical reduction positions of pelvis at the end of operations
2. The intra-operative complications, such as wound infection, nerve or vascular injury, are recorded and retrieved from the medical electric records after the operations
Secondary outcome measures
The mean duration for the setup of the frame, the virtual surgery simulation, and the reduction of the unstable pelvic fractures, were recorded by our researchers during operations.
Overall trial start date
11/01/2014
Overall trial end date
28/02/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. The unilateral unstable pelvic fractures and displacements
2. Adults aged 18 or over
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
Bilateral unstable pelvic fractures or stable pelvic fractures.
Recruitment start date
01/01/2015
Recruitment end date
31/08/2016
Locations
Countries of recruitment
China
Trial participating centre
Chinese PLA General Hospital
28 Fuxing Road
Haidian District
Beijing
100853
China
Funders
Funder type
Hospital/treatment centre
Funder name
Chinese PLA General Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Analysis of relevant data of this study has been carried out. The main results will be published in a high-impact peer-reviewed journal.
IPD sharing statement:
The data sharing plans for the study will be made available at a later date.
Intention to publish date
01/07/2018
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary