The aim of the four imaging studies in this combined protocol is to investigate the bilateral symmetry of the human ankle joint using quantitative 3D computed tomography (Q3DCT); the accuracy of the medial distal tibial angle as measured on two…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1.Investigating bilateral symmetry on 3DCT:
Bilateral symmetry of the tibia and fibula by grade of symmetry (in percentage).
2. Medial Distal Tibial angle 2D-Xray versus 3DCT
MDTA as measured on reconstructed AP X-ray in degrees: angle between the joint
orientation line and the mechanical axis of the tibia. In 2D-Xray, the axes are
determined by manual geometric measurements. The mechanical axis is the line
between proximally the midpoint of the tibia plateau and distally the midpoint
of a circle drawn to touch all three cortices of the tibial meta-epiphysis.
MDTA measured with Q3DCT: the mechanical axis of the tibia passes through the
centre of the knee joint line to the centre of the ankle plafond. After
segmentation of the bones out of the 3DCT image, the axes can be automatically
determined by calculating the axes of inertia, which is based on principle
component analysis yielding three orthogonal vectors (the direction of the
axes) and three eigenvalues. The axis with the smallest eigenvalue identifies
the long axis of the bone, the z-axis. The origin is chosen where the z-axis
intersects the vitual bone surface. The x-axis is perpendicular to the z- axis
and points in the direction of the distal tip of the medial malleolus. The y-
axis is orthogonal to the x-, and z-axes.
3. Hindfoot Alignment views 2D-Xray versus 3DCT
The percentage of variation of translation of the MLA over the tibiotalar joint
line as measured by the method of Haraguchi et al as induced per 5 degrees
deviation of the projection angle.
4. Orientation and shape of the articular surface of the subtalar joint on 3DCT
To describe the 3D orientation of the normal of the articulating joint facets
in a coordinate system based on the principle axes of the calcaneus, the talus
and the mechanical leg axis (MLA). Means and SD will be given as a new standard
reference for a healthy population.
Secondary outcome
1. Investigating bilateral symmetry on 3DCT
Differences between the left and right tibia and fibula are described by
differences in length in coronal and sagittal axis, width (both in mm), angles
(in degrees), rotations (in degrees) and joint orientation of the tibial
plateau and the tibial plafond compared to each other and the mechanical axis
(in degrees).
2. Medial Distal Tibial angle 2D-Xray versus 3DCT
Not applicable.
3. Hindfoot Alignment views 2D-Xray versus 3DCT
Assessment of inter and intraobserver reliability as measured using the
intercorrelation coefficient.
4. Orientation and shape of the articular surface of the subtalar joint on 3DCT
To describe the 3D shape of the articulating joint facets expressed by the
parameters of a saddle shape. Curves of the saddle are described as being part
of a circle (percentage of the full circumference) with a given radius (in mm).
Means and SD will be given as a new standard reference for a healthy
population.
Background summary
Ankle joint problems after injury are a major social-economic burden. Treatment
outcomes vary due to a lack of quantitative data. It is of great importance to
gain better understanding of the anatomy to ensure optimal patient care. Both
fracture treatment as well as correction of malalignment could benefit from a
better understanding and graphic depiction of the anatomy. Fracture union with
deformity (malunion) is a common complication after an ankle fracture. A
corrective osteotomy should correct three-dimensional positioning parameters
(translations and rotations). In preoperative planning the unaffected leg could
serve as a template for the injured leg, but basic 3-dimensional anatomical
studies are necessary to assess the level of bilateral congruency. Currently
bilateral symmetry is assumed, despite the lack of quantitative research on
this topic. Establishing the extent of bilateral symmetry would mean a
break-through in the research, treatment and preoperative planning of various
lower leg abnormalities, especially in procedures that require patient-
specific instruments. In addition to comparison by computed tomography (CT) for
bone symmetry, malalignment is also assessed using standing long-leg
radiographs. In case of malalignment this is a cheaper method compared to a CT
scan. However, the influence of projection angle deviation is unknown,
something that may be assessed using 3DCT models.
Study objective
The aim of the four imaging studies in this combined protocol is to investigate
the bilateral symmetry of the human ankle joint using quantitative 3D computed
tomography (Q3DCT); the accuracy of the medial distal tibial angle as measured
on two dimensional (2D) radiographs compared to Q3DCT as a reference standard;
the optimal projection angle for a lower leg alignment view used to assess
hindfoot alignment; and to investigate the anatomy of the subtalar joint. Q3DCT
is an ideal tool for these four studies as it provides the possibility to
measure in 3D and is more accurate than Q2DCT.
Through performing the above-mentioned studies, we will acquire valuable
information concerning lower leg symmetry, anatomy and alignment which can be
used as fundamental basis in patient treatment. This Q3DCT database can also be
used for future research purposes.
Study design
Descriptive imaging study
Study burden and risks
The radiation exposure of scans is estimated to be in the order of 0,5 mSv per
participant. This exposure lies in the category IIa (0-1 mSv) of the ICRP
qualified as a minor risk. This study carries no direct benefit for the
participating volunteers, however, these techniques will be of benefit in
preoperative planning for future patients with malalignment requiring
reconstructive surgery.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Healthy volunteers
- Over the age of 18 years
- Both legs are unaffected
Exclusion criteria
- Injury/ disorders or serious complaints of the leg/ankle/foot in history
- Familiar with skeletal and/or connective tissue diseases
- For females: pregnancy
- Not able to understand and/or give written informed consent
- Underwent a CT-scan 1<= year ago or has a CT-scan planned within the upcoming year
Design
Recruitment
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 | NL60684.018.17 |