Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05397327 |
| Other study ID # |
NL2022-13629 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2022 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
May 2022 |
| Source |
Radboud University Medical Center |
| Contact |
Jellina Huitema, MD |
| Phone |
+31243613808 |
| Email |
jellina.huitema[@]radboudumc.nl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Tibial plateau fractures are often complex fractures and need a good preoperative planning.
The investigators think that a 3D virtual planning software will help the surgeons to get a
better understanding of the fracture and therefore want to study the value of 3D virtual
planning software in the preoperative planning of tibial plateau fractures. The investigators
hypothesize that this software will shorten the duration of surgery, decrease the
peroperative bloodloss and the number of complications.
Patients with tibial plateau fractures who need surgical treatment will be asked to
participate in this study. After participants have given informed consent, they will be
randomized between a 'traditional preoperative planning' and a '3D virtual preoperative
planning' group. Surgeons will plan their surgery using traditional planning tools (X-rays
and CT scan) or traditional planning tools ánd the 3D virtual planning software.
6 weeks, 3 months and 6 months after surgery, participants will be asked to fill in 2
questionnaires about knee pain and knee function. After surgery a CT scan or X-ray will be
performed conform standard of care in the hospital.
Description:
Patients with tibial plateau fractures are traditionally challenging to treat, especially the
complex fracture patterns in which anatomic reconstruction of the articular surface can be
very demanding. In a previous study, the researchteam showed that surgical decision-making
should be guided by recognition of specific fracture characteristics, rather than the
'classic' classification of fractures by Schatzker. Recognition of these specific tibial
plateau fracture patterns has been proven reliable and reproducible to guide surgeons plan
their approach, reduction techniques and fixation.
Building on our improved understanding of (complex) tibial plateau fracture patterns, and how
these specific fracture characteristics guide our surgical management, the next step includes
meticulous pre-operative surgical planning to achieve the best functional results for our
patients. A new state-of-the-art tool is currently available to aid surgeons in 3D virtual
planning of approach, reduction strategy, and even application of hardware (i.e. size of
plates and lengths of screws (https://sectra.com/medical/product/sectra-3d-trauma/).
Recent studies on virtual surgical planning for fracture care have shown variable results.
One study concluded that there was a significant reduction in duration of surgery in about
75.0% of all cases. Another study showed improvement of the outcomes of acetabular fracture
surgery by reduced duration of the surgery and improved quality of the reduction. However, a
third study showed that 3D virtual reality is inferior compared to 3D printed models on
acetabular fractures in terms of interobserver agreement. In conclusion, the added value of
virtual preoperative planning has yet to be determined.
If virtual surgical planning is as promising as some of the previous results show, it could
also have a significant impact on the surgical reduction in the treatment of tibial plateau
fractures. This might lead to a reduction of duration of surgery, less complications and
better patient related outcomes, such as postoperative pain and knee function.
Therefore, the investigators would like to compare the conventional preoperative planning
with the preoperative planning with use of the virtual planning software of Sectra AB for
tibial plateau fractures in terms of duration of surgery, surgical complications and patient
related outcomes.
To see if the virtual planning software is comparable with the postoperative situation, the
investigators would like to compare the preoperative virtual plan with the postoperative CT
scan in terms of residual displacement and placement of the osteosynthesis material.
Primary Objective:
What is the added value of pre-operative virtual 3D surgical planning compared to traditional
pre-surgical planning (i.e. surgeons' interpretation and written planning of standard 2D- and
3D CT-imaging) in patients with tibial plateau fractures in terms of duration of surgery?
Secondary Objective(s):
What is the added value of pre-operative virtual 3D surgical planning compared to traditional
pre-surgical planning (i.e. surgeons' interpretation and written planning of standard 2D- and
3D CT-imaging) in patients with tibial plateau fractures in terms of
- postoperative complications?
- peroperative deviations of surgical planning?
- quality of post-operative reduction (i.e. reduction of step-off)?
- patient related outcomes (i.e. postoperative pain and knee function)?
For this study, the investigators have chosen to perform a randomized controlled trial to
reduce the risk of selection bias. Participants will be divided in two groups, where in the
conventional group trauma surgeons will plan their surgery using X-rays, 2D and 3D CT scans.
In the virtual group, surgeons will plan their surgery using the virtual 3D planning software
of Sectra AB and X-rays, 2D and 3D CT scans.
In both groups, surgery will be performed conform standard of care. This means that the
preoperative planning is used as a guideline for the surgery and there will be deviated from
the planning if deemed necessary for the surgery.
Postoperative, surgeons will be asked to fill in questionnaires to determine deviations of
the preoperative plan, time spent planning and satisfaction. Patients will be asked to fill
in questionnaires to determine functional outcome and health related quality of life, a
postoperative CT scan will be performed after surgery to determine quality of postoperative
reduction, according to our standard-of-care.
Quality of reduction on a CT or X-ray does not always match with patient experienced
outcomes. Therefore, the investigators have chosen to not only measure quality of reduction,
but also patient related outcomes, such as postoperative knee function and health related
quality of life. Because of this possible mismatch, the investigators have chosen for
reduction of operation time as our primary outcome. A longer operation time is associated
with more postoperative surgical complications and blood loss. Furthermore, operation time is
valuable and therefore expensive. A reduction in operation time would therefore not only have
an effect on patient related outcomes, but also have effect on healthcare costs.
This study will take place at the following three level I trauma centers:
- Flinders University Medical Center, Adelaide, Australia
- Radboud University Medical Center, Nijmegen, the Netherlands
- Massachusetts General Hospital, Boston, United States of America
The investigators will ask patients who present themselves at the emergency department with a
tibial plateau fracture that needs surgical treatment within 14 days of the injury to
participate in this study. If they are willing to participate, an informed consent will be
signed and furthermore, they will receive an information folder with specified information
about this research study.
Surgical residents and surgeons will be informed about this study through an e-mail with a
short outline of the research. They will be asked to inform the researcher when there is a
patient with a tibial plateau fracture who needs surgical treatment. The researcher will
visit the emergency department or ward to inform the patient and sign the informed consent. A
patient can give informed consent until two days before the planned surgery to ensure the
trauma surgeon has enough time to plan the surgery thoroughly.
When included, patients will randomly be divided into two groups through sealed opaque
envelopes:
- Group 1: preoperative planning using the 3D virtual planning software of SECTRA
- Group 2: traditional preoperative planning (i.e. surgeons' interpretation and written
planning of standard 2D- and 3D CT-imaging).
Concealed randomization will be obtained with the randomizer.org software and stratified by
centers.
Per trauma center, the investigators will train three experienced trauma surgeons in using
the SECTRA 3D virtual planning software. These surgeons perform the majority (i.e. 95%) of
all patients admitted with tibial plateau fractures. The investigators will ask the surgeons
from both the traditional and virtual planning groups to keep track of time they spent
planning the surgery. After planning the surgery, the surgeons will fill in a questionnaire
where they indicate their surgical plan (i.e. which screws and plates they are planning to
use and which surgical approach they attend to perform) and time spent planning.
After the surgery, the surgeons will fill in a questionnaire where they will indicate if they
deviated from the pre-operative plan and if they are satisfied with the postoperative result.
Using the operative notes, the investigators will determine the used screws, plates and
surgical approach and the total duration of surgery.
Postoperative patients will get a CT-scan to determine the quality of the postoperative
reduction. After 6 weeks, 12 weeks and 6 months the investigators will determine functional
outcome and health related quality of life using the 'Knee injury and Osteoarthritis Score'
(KOOS) questionnaire, and the Short Form - 36 (SF-36) questionnaire.
The investigators will use CastorEDC for creating the patient and surgeon questionnaires and
for storing patient information at the secured digital research environment of Radboud
University Medical Center. All patient and surgeon information will be pseudonymized by the
department of Radiology and Nuclear Medicine of the participating hospital, therefore
subjects privacy is protected. This key will be deleted after data collection is finished.
For analysis, these questionnaires will be exported to SPSS. The data of the statistical
analysis and the results will also be stored at the secured digital research environment. The
data will be kept for 15 years. Only researchers involved in the study have access to the
data.
