To longitudinally evaluate the substantial differences in anatomical changes in the spine during adolescent growth in girls, at increased risk for scoliosis development, and in adolescent 22q11.2DS patients, that do and do not develop AIS.
ID
Source
Brief title
Condition
- Other condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Synonym
Health condition
scoliose
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the longitudinal changes in segmental axial
rotation on MRI of the thoracolumbar spine in subjects that do and do not
develop AIS.
Secondary outcome
1. Changes in bone and intervertebral disc morphology (A-P, left-right ratio,
torsion, volumes, shift of the nucleus pulposus) during growth.
2. Changes in spinal alignment during growth
3. Spine specific (IVD/endplates) maturity assessment grading.
4. Spine specific maturity assessment grading in relation to:
o Skeletal maturity (Greulich and Pyle digital skeletal age)
o Biological maturity (age, menarche, as well as potential markers for
endochondral ossification identified in the future that can be measured on the
samples in the concurrent biobank of this study population (examples are vit D,
serum collagen X matrix, Osteopontin)
o Generalized joint hypermobility (Beighton/Bulbena score)
o Spinal alignment and length in the upright position and supine position
o Spinal cord morphology changes (conus level) during growth
o Chest wall shape development (shape, size and volume)
All above in subjects that do versus those that do not develop scoliosis
Background summary
The cause of the most common form of scoliosis is not yet known. We do know
that it usually occurs in girls during the growth spurt and we suspect that it
has to do with the growth of the intervertebral discs and posture during growth
spurt. If the bend test is abnormal, the size of the scoliosis can be measured
on an X-ray and is expressed in degrees (the Cobb angle, see figure 2). This
Cobb angle is used by the orthopedist to monitor the severity of scoliosis.
Scoliosis is only diagnosed if the Cobb angle on the X-ray is greater than 10
degrees. Children are monitored at a Cobb angle below 20 degrees. Growing
children with a bend above 25 degrees are braced to prevent further increase in
scoliosis. If the growth scoliosis increases above 45 degrees, surgery is
suggested, as this severe scoliosis can continue to progress for the rest of
life.
Study objective
To longitudinally evaluate the substantial differences in anatomical changes in
the spine during adolescent growth in girls, at increased risk for scoliosis
development, and in adolescent 22q11.2DS patients, that do and do not develop
AIS.
Study design
Prospective, obsevational cohory study
Intervention
N/A
Study burden and risks
Participants have a higher risk for development of idiopathic scoliosis
compared to their peers and scoliosis can be diagnosed and treated at an early
stage. This study can only be done using these patients groups. MR imaging is
nonionizing and gives no noteworthy risk. Therefore the risks associated with
participating in this study are negligible and the burden minimal.
Heidelberglaan 100
UTRECHT 3584 CX
NL
Heidelberglaan 100
UTRECHT 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Cohort 1:
- Female,
- 8, 9 or 10 years old
- An older sibling, twin or parent diagnosed with AIS
- No clinical signs of scoliosis at inclusion (physical examination by forward
bending test and Bunnell Scoliometer assessment with a cut-off value of 7°.
- Written informed consent of parents/legal representatives.
Cohort 2:
- Diagnosed with 22q11.2DS
- Girls: 8, 9 or 10 years old.
- Boys: 9, 10 or 11 years old.
- No clinical signs of scoliosis at inclusion (physical examination by forward
bending test and Bunnell Scoliometer assessment with a cut-off value of 7°.
- Written informed consent of parents/legal representatives.
Exclusion criteria
• Contraindications for MR imaging
• Early-onset scoliosis or other spinal deformities
• Other syndromes or neuromuscular disease associated with scoliosis
• Clinical signs of >1cm leg length discrepancy
• Other diseases or injuries, that are related to abnormal spinal growth,
posture, activity levels, or scoliosis development.
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 | NL82419.041.22 |