Condition category
Injury, Occupational Diseases, Poisoning
Date applied
09/11/2017
Date assigned
10/11/2017
Last edited
10/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Chinese PLA General Hospital

Sponsor details

28 Fuxing Road
Haidian District
Beijing
100853
China

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes