To obtain the reproducibility of the standing posture using with Der Wippe, a balancing device, with adjustable holder and acquire the 3D ultrasound of the spine of scoliotic patients
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders congenital
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter of the posture reproducibility study will be the
reproducibility of the posture in the different set-ups.
Secondary outcome
The main study parameters of the 3D ultrasound imaging and the MRI of the spine
will be vertebral features.
Background summary
Background :
Frequent monitoring of scoliosis progression is effective to define the
severity and determine the best treatment.
X-ray is the gold standard to measure the spinal curvature in scoliosis,
however, radiation exposure in X-ray limits the frequent monitoring of
scoliosis to only twice a year.
Positional variability in spinal X-ray radiography could cause the wrong
diagnosis and non-adequate or unnecessary treatment of scoliosis.
Vertebral arch surface reflection in 3D ultrasound imaging shows feasibility of
utilizing this imaging system for monitoring scoliosis progression frequently
in a safer way.
The prospective development of 3D ultrasound imaging for frequent monitoring of
scoliosis requires a reproducible standing posture procedure.
Study objective
To obtain the reproducibility of the standing posture using with Der Wippe, a
balancing device, with adjustable holder and acquire the 3D ultrasound of the
spine of scoliotic patients
Study design
The study consists of two parts:
1) a posture reproducibility test applied for X-ray and ultrasound
2) a 3D ultrasound imaging of the spine taken in supine and standing positions.
Both parts are relevant for a future prospective cohort study.
Study burden and risks
This study has negligible risks and the burden is minimal. The posture
reproducibility study for X-ray as well as ultrasound will only apply safe
replica devices to mimic the real procedures. The postural movement will be
measured using body markings derived from photographs taken with commercial
digital cameras. The 3D ultrasound imaging of the spine will not impose any
radiation exposure to the subjects and have no harmful side effects. X-ray
images are not part of our study but obtained as part of standard medical
procedures in these patients. For the MRI in healthy subjects, standard
precautions are taken (MRI exclusion criteria) so that this part of the study
also has minimal risks.
The posture reproducibility measurements will be performed on the same day as
the patient has her regular appointment with the orthopedic surgeon, right
before and after the consultation time. The 3D ultrasound imaging of the spine
will be performed at a different day than the posture reproducibility test, but
also in combination with an appointment with the orthopedic surgeon. Every part
of the study will require 60 to 90 minutes per subject per session.
The physical and physiological discomfort associated with the study is very
small. Participants in the study have no direct benefit from the study. In the
long term, the results of this study may benefit the group of scoliotic
patients because a more accurate standing posture may be determined and the
amount of radiation involved in follow-up of scoliosis may be limited.
Antonius Deusinglaan 1
9713 AV, Groningen
NL
Antonius Deusinglaan 1
9713 AV, Groningen
NL
Listed location countries
Age
Inclusion criteria
Idiopathic & congetinal scoliosis
Female / Girl
Age between 12 and 18 years old
Under treatment at scoliosis clinic in UMCG
Capable of standing up normally without any supporting devices
Range of Cobb angle : between 20° and 60 °
Exclusion criteria
Pregnancy
Accomplished spinal surgery
Back pain
Neurological disorder
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 | NL29540.042.09 |