Primary Objective: This study aims to detect early changes in the morphology and MRI signal of the IVDs during scoliosis progression.Secondary Objective(s): 1. To correlate the findings on MR -imaging with patient-reported outcome measurements…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Each MR scan will consist of a standard sagittal-only T2W, developed for IVD
imaging. The IVDs of the spine between T1 and S1 will be scanned. The different
parameters will be measured semi-automatically.
The primary study parameters are changes in MRI timing, sensitivity, dynamic
range, spatial distribution and morphological changes of the IVD during AIS
progression.
Secondary outcome
The secondary parameters are:
1. Correlation of the findings on MR-imaging with patient-reported outcome
measurements using the SRS-22 questionnaire
Background summary
Adolescent idiopathic scoliosis (AIS) is a three-dimensional (3-D) deformity
not only affecting the spine but the entire trunk. Significant scoliotic
deformities may have serious adverse effects including cardio-respiratory
problems, back pain, cosmetic concerns, social and psychological problems and
the financial costs of treatment. Despite many years of extensive research, the
exact aetiology remains unclear. Another topic of discussion is the ability to
predict (rapid) curve progression; there are no prognostic factors identifying
the group at risk for rapid progression.
Changes in the mechanical properties of the intervertebral disc (IVD)
have been associated with onset and progression of AIS. The IVD, the most
important stabilizer of the spine, consists of a fibrocartilaginous ring called
the annulus fibrosis and a gel-like core, the nucleus pulposus (NP), which
mainly consists of proteoglycans and collagen. To date, some changes in the
IVD have been reported in progressive scoliosis. Mostly in terms of tissue
composition of scoliotic discs removed during surgery. Recent data showed at
least three times more deformation in the IVD compared to the vertebral body in
all three planes of a scoliotic curve. These findings suggest that AIS is
mainly a 3-D deformity of the IVD and that abnormal vertebral growth, according
to Hueter-Volkmann*s law, is a consequence rather than a cause of AIS. This
greater contribution of the IVD to the 3-D deformity is likely caused by lower
stiffness of the intervertebral fibrocartilage as compared to the bony
vertebrae.
However, research into the changes occurring within the IVDs of the
scoliotic spine is limited by the lack of proper animal models and the
impossibility of analyzing human tissue during progression. This problem can be
overcome by mapping the changes in the IVDs using novel MR-based imaging,
determining the composition and integrity of cartilaginous tissues, without any
invasive procedures or radiation involved.
Study objective
Primary Objective:
This study aims to detect early changes in the morphology and MRI signal of
the IVDs during scoliosis progression.
Secondary Objective(s):
1. To correlate the findings on MR -imaging with patient-reported outcome
measurements using the SRS-22 questionnaire
In total we will make three MR scans of each patient; t=0, t=6 months.
Study design
Prospective cohort study.
Study burden and risks
The results from this study will provide us with more knowledge about the role
of the IVD in the progression of AIS and may also shed light on its potential
role in the development of this deformity. Data on the MRI-based changes in the
IVD occurring in AIS might be used in the future as a prognostic factor for
children who already have AIS, and possibly intervene earlier with
non-operative treatments in which -to be developed- regenerative medicine
strategies may be employed. There are no noteworthy risks associated with
participating in this study, and no invasive procedures or contrast
administration will be performed.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Patients diagnosed with adolescent idiopathic scoliosis
- Presence of right convex main thoracic structural curve, either in Lenke type
1 or 2;
- Female gender
- Between 10-16 years of age
- Cobb*s angle 20-40 degrees
Exclusion criteria
- Skeletal maturity
- Presence of any additional spine pathology such as spondylolysis or
-listhesis, M. Scheuermann, congenital spinal abnormalities, spinal tumors and
spinal trauma
- Previous spinal surgery
- Neurological symptoms, deficits or pathology
- Syndromes associated with disorders of growth
- Any contra-indication for MR Imaging
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 | NL58104.041.16 |