Primary objective: To create and validate healthy-subject-specific musculo-skeletal models of the lower extremity. We will also develop a new method using the Positron Emission Tomography (PET) technique that can be used to validate musculo-skeletal…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary outcomes are anatomical and physiological musculo-skeletal
parameters. The anatomical parameters are extracted from MRI scans. They
consist of muscle attachment points, muscle wrapping contours, muscle volumes,
bony landmarks, tendon lengths and physiological cross-sectional areas of
muscles. Physiological parameters are measured from kinematic and ground
reaction force data, surface electromyography, oxygen measurements, and PET
during various activities. They consist of torque around the hips, knees and
ankle joints, joint compression forces, muscle activition timing, muscle force
production and muscle energy consumption. The latter two are particularly
important to validate because they are primary outcomes of the M-S models.
Muscle energy consumption will be measured with PET.
Secondary outcome
Not applicable.
Background summary
A state-of-the-art musculo-skeletal (M-S) model of the lower extremity (TLEM -
the Twente Lower Extremity Model) has recently been developed. The ability to
perform activities of daily living after surgery can be simulated in the model.
The goal of the TLEMsafe project is to use this model to improve the safety and
predictability of M-S surgery. The model will have to be made patient-specific
and undergo rigorous validation to achieve this goal. In this first part (the
validation part) of the project, healthy-subject-specific M-S models will be
created from parameterization of MRI scans. The models will then be validated
by comparing model-simulated predictions about the performance of maximum
voluntary contractions (MVCs) and basic activities of daily living to real-life
measurement data (e.g. 3-D kinematics, ground reaction forces, muscle
activation timing, muscle energy consumption) of such activities as they are
performed by subjects in the motion laboratory. We will also use the PET scans
to develop a new method for validation of musculo-skeletal models.
Study objective
Primary objective: To create and validate healthy-subject-specific
musculo-skeletal models of the lower extremity. We will also develop a new
method using the Positron Emission Tomography (PET) technique that can be used
to validate musculo-skeletal models in general. The PET scans thus serve two
purposes. They offer us energy consumption data with which we can validate our
models, but also serve as a basis for the development of a new method that can
be used to validate musculo-skeletal models in general. Such a method does not
yet exist in the literature. Therefore, the PET scans offer interesting
publication opportunities.
Study design
Observational prospective cohort study.
Study burden and risks
Participation entails three measurement sessions at the Radboud University
Nijmegen Medical Center and the Sports Medical Center of the Sint
Maartenskliniek.
Session one takes place at the department of Radiology and the department of
Nuclear Medicine. It consists of a magnetic resonance imaging (MRI) scan, a
positron emission tomography/computed tomography (PET/CT) scan and an oxygen
consumption measurement during walking. Both the MRI scan and the PET/CT scan
are made exclusively of the lower extremity. To correct the PET scan images for
attenuation by the body, a low-dose attenuation CT scan will be made during the
PET scan. Subjects will be injected with 50 MBq [18F]Fluorodeoxyglucose (FDG).
The combined PET/CT scan results in an effective dose of about 3 mSv. This
session takes approximately four hours to complete.
Session two takes place in the motion laboratory of the department of
Rehabilitation. In session two, 3-D kinematics, ground reaction forces,
electromyography and ultrasound scans will be employed to measure physiological
parameters and task performance during MVCs and basic activities of daily
living such as walking, getting up from and sitting down on a chair, and
stepping over an obstacle. All of these measurements are very common in this
laboratory and are painless and non-invasive. This session takes approximately
three hours to complete.
In session three, subjects perform isokinetic and isometric contractions of the
joints of the lower extremity. Specifically, flexion and extension of the hip,
knee and ankle and abduction of the hip will be tested. The setup that will be
used to measure the isokinetic and isometric contractions is a Humac Norm,
which is a commercially available apparatus designed specifically for
performing these measurements. It has already been used for many other studies
in the literature without the occurrence of adverse events.
Reinier Postlaan 4
6525 CG Nijmegen
NL
Reinier Postlaan 4
6525 CG Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Healthy, age 18-60, body mass index 17-30.
Exclusion criteria
Deformities of the musculo-skeletal system such as scoliosis and hip dysplasia.
Use of medication that affects the functioning or the neurological control of the musculo-skeletal system.
Having had major injury or orthopedic surgery of the lower extremity at any time during life.
History of ailment related to carbohydrate metabolism, or to cardiac or muscular disease.
Being pregnant or having the intention to become pregnant during the course of the study.
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 | NL35063.091.11 |