To assess the following research questions: 1. Does the use of 3D virtual preoperative planning of surgery improve functional outcome as measured by Patient-Reported Outcome in comparison to conventional surgery (using conventional radiographs and/…
ID
Source
Brief title
Condition
- Bone and joint injuries
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The primary endpoint is patient-reported outcome, which will be assessed
with validated follow-up questionnaires.
Secondary outcome
2. The secondary endpoint is the residual fracture displacement (gap and
step-off in mm), as measured on the postoperative CT-scan.
3. The tertiary endpoint is operation efficiency in terms of operation time
(minutes), blood loss (mL) and radiation exposure (mGym2).
4. The last endpoint is the cost effectiveness.
Background summary
In surgical treatment of intra-articular fractures, achieving an optimal
anatomical reconstruction improves the functional outcome. These fractures
often consist of complex fracture patterns with multiple fragments displaced in
different directions, and are considered among the most complicated fractures
to treat. Currently, the surgical strategy is based on conventional imaging
methods such as plain radiographs and/or a 2D CT scan. However, 2D assessments
of these complex multi-directional fractures are known to be highly user
dependent and tend to underestimate the displacement. 3D visualizations of the
fracture might provide the surgeon with a better understanding of the fracture.
Pre-operative 3D virtual planning could therefore help to improve the surgical
outcome in terms of quality of the fracture reduction and reduce operation
time, blood loss and radiation exposure.
Study objective
To assess the following research questions:
1. Does the use of 3D virtual preoperative planning of surgery improve
functional outcome as measured by Patient-Reported Outcome in comparison to
conventional surgery (using conventional radiographs and/or 2D CT images)?
2. Does the use of 3D virtual planning of the surgery improve fracture
reduction?
3. Does the use of 3D virtual planning of surgery increase operative efficiency
in terms of operation time, blood loss and radiation exposure?
4. What is the cost effectiveness of 3D assisted surgery?
Study design
All patients who will be included in this Randomized Controlled trial will be
operated for an intra-articular fracture of the wrist, knee or ankle and
randomized between preoperative planning with conventional imaging (control
group) or a 3D virtual fracture model (intervention group).
Intervention
In the intervention group, surgery will be prepared by using a 3D
virtual fracture model (based on the CT images) in addition to conventional
imaging. In the control group the preoperative planning will be
performed by using conventional imaging (i.e. radiographs and/or 2D CT images)
according to the standard of care.
Study burden and risks
The extent of burden and risks for patients participating in the study is
considered low, because the operative procedure itself will not change. The
surgery and follow-up will be performed according to the standard of care. The
only addition is that in the intervention group surgery will be prepared by
using a virtual 3D model of the fracture as an addition to the conventional
images. The operative procedure itself won*t change. With the outcome of this
study, we intend to present the results at international conferences and
publish them in international peer-reviewed journals.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Acute fractures (<3 weeks after the initial injury)
- Fracture of one of the following body regions (distal Radius, proximal Tibia,
distal Tibia/Ankle, see table below for specific fracture types that are
eligible for inclusion)
- Operative treatment
- Availability of a diagnostic (Pre-operative) CT-Scan available (Slice
thickness <= 1 mm)
- Age >= 18 years
- Understanding of the Dutch language
Table: Fracture types which are eligible for inclusion.
Nr Fracture Location AO classification
1 Radius Distal 2R3B; 2R3C
2 Tibia Proximal 41B; 41 C
3 Tibia/Ankle Distal 43B; 43C / 44B/C with tertius fragment
Exclusion criteria
- Age < 18 years
- Previous injury with persistent functional impairment of the fracture site
- Non-operative treatment
- Complicated (open) fractures requiring a free flap
- Pathological fractures
- No understanding of the Dutch language
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81122.042.22 |