Early experience with treatment of unstable pelvic fracture using a computer aided system
| ISRCTN | ISRCTN38873803 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38873803 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/11/2017
- Registration date
- 10/11/2017
- Last edited
- 01/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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)
Contact information
Scientific
Department of Orthopaedics
Chinese PLA General Hospital
28 Fuxing Road
Haidian District
Beijing
100853
China
Scientific
Department of Orthopaedics
Chinese PLA General Hospital
28 Fuxing Road
Haidian District
Beijing
100853
China
Study information
| Study design | Prospective single-center single-group interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Early experience with reduction of unstable pelvic fracture using a computer aided reduction frame |
| Study objectives | 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(s) | Institutional Ethical Review Committee of Chinese PLA General Hospital, 01/01/2015 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 11/01/2014 |
| Completion date | 28/02/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. The unilateral unstable pelvic fractures and displacements 2. Adults aged 18 or over |
| Key exclusion criteria | Bilateral unstable pelvic fractures or stable pelvic fractures. |
| Date of first enrolment | 01/01/2015 |
| Date of final enrolment | 31/08/2016 |
Locations
Countries of recruitment
- China
Study participating centre
Haidian District
Beijing
100853
China
Sponsor information
Hospital/treatment centre
28 Fuxing Road
Haidian District
Beijing
100853
China
"ROR" |
https://ror.org/04gw3ra78 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/07/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The data sharing plans for the study will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/02/2018 | 01/12/2022 | Yes | No |
Editorial Notes
01/12/2022: Publication reference and total final enrolment added.
