Our overall aim of the our project is to evaluate the long-term treatment effects of bracing and surgery in patients with adolescent idiopathic scoliosis, with a minimum 25 years follow-up. Secondly, to determine clinical and/or radiological…
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Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Signs of osteoarthritis can be quantified by radiography in 2 directions
(Posterior-Anterior and
lateral) . Signs of osteoarthritis will be classified by Pathria,
Kellgren-Lawrence and Weishaupt
classification.
Signs of DDD will quantified by the total number of degenerated disc per
subject and the
proportion of degenerated discs. In addition, proportion of discs with
Schmorl*s nodes, discs
herniation and discs with inflammatory end plate changes will be determined.
Secondary outcome
The radiological results may be correlated to patients demographics, curve
types (e.g. Lenke
classification) , size of the remaining curve, parameters of spinal balance or
clinical outcomes of our
BASIS study (a previous study of ours which evaluated long-term clinical
self-reported outcomes
with the following questionnaires: Health related quality of life: SF-36,
EQ-5D, SRS-22& and low
back pain: Oswestry Disability Index and visual analogue scale)
The spirometry will be compared to the one performed during childhood to
examine the difference
in pulmonary functioning over the years.
The DISCUS study protocol describes the inclusion of three patient groups:
group 1 is operated on and had a curvature of 45-55 degrees before surgery
(after correction, their curvature measures 20-25 degrees), group 2 is
non-operated and has a curvature of approximately 20-25 degrees at the end of
growth, and group 3 is non-operated with a curvature of 45-55 degrees at the
end of growth (similar to group 1 before surgery). Groups 1 and 3 have already
completed all examinations, and interim results show minimal disc degeneration
in group 3 on the MRI scan. Therefore, we expect that MRI scans of group 2
(with less scoliosis than group 3) will not provide additional value, and we
intend to refrain from including this patient group to avoid subjecting them to
unnecessary research.
However, we observe significant scoliosis progression in group 3 (classified as
severe scoliosis with a Cobb angle of 45 degrees) based on the new X-rays. We
would like to expand this research group by obtaining X-rays of more patients
with non-operated scoliosis and a curvature of 45 degrees. This population has
previously participated in the study on Health Related Quality of Life (BASIS
WO15.017) and has already provided consent to be approached for follow-up
research. This group consists of 22 patients.
Expanding the sample size of scoliosis patients from "Group 3" aims to provide
valuable insights into the curvature progression of non-operatively treated
scoliosis after growth completion. Before obtaining new X-rays, we will inquire
whether patients have had X-rays taken at another hospital in the past 5 years
and if we may request those images. If available, it will not be necessary to
take new X-rays.
The findings will contribute to a better understanding of the long-term
outcomes and can support clinical decision-making for this patient population
Background summary
Scoliosis is the most common deformity of the spine affecting approximately
2-3% of children
younger than 16 years of age4. In 0.3-0.5% of the children, the spinal curve
becomes progressive
and requires treatment. It is a complex three-dimensional deformity of the
spine that presents
during childhood, and usually worsens during adolescence. It is ten times more
common in female
than in males. The most common scoliosis is the idiopathic scoliosis which
means there is no
definite etiology. The curve can cause pain, shortness of breath and fatigue on
young age. Most
children with scoliosis do not have complaints of the deformity. The treatment
of the
asymptomatic adolescent scoliosis patients aims to prevent future problems,
like osteoarthritis of
the spine and degenerative disc disease. The goal of the treatment is a curve
with a angle of less
than 45 degree at skeletal maturity. Natural history studies indicate that
curves bigger than 45
degree tend to progress after skeletal maturity due to gravity. If curves
become larger, the more
the spine is out of his equilibrium, which cause an asymmetric force on spinal
joints en discs.
Besides osteoarthritis of the spine, major curves can cause nerve, heart, lungs
and psychological
problems.
Treatment of idiopathic scoliosis attempts alter the natural history of the
disease. The only proven
conservative treatment is brace treatment. Children have to were the brace
during a few years of
their growth spurt 20 hours a day and is only effective in rapidly growing
immature patients with a
mild spinal curvature (25-45 degrees). Severe curves over 45 degrees are an
indication of surgical
treatment. Surgical treatment does not completely cure scoliosis, but helps to
correct the curve by
approximately 50% and manage curve progression by fusing a large area of the
spine to prevent
further progression. The aim of the brace is to stop progression and maintain
the curve below 45
degrees thereby leaving the patient with a deformity with lesser risk of
problems in later life. A
recent randomized controlled trial confirmed the efficacy of bracing in
idiopathic scoliosis with
level-1 evidence by showing a significant reduction of curve progression and
subsequent reduction
of the need for surgery.
Despite treatment in adolescence, few patients experience problems during
adolescence.
Treatment of the asymptomatic adolescent scoliosis patients aims to prevent
future problems.
Many adult scoliosis patients experience back pain caused by osteoarthritis and
degenerative disc
disease4. Backpain and poor self-image due to the cosmetic deformity can result
in social and
psychological problems. Although scoliosis treatment is focused on long-term
problems, only few
scoliosis studies have studied the long term outcomes of current surgical and
non-surgical
treatments. There is evidence that surgery of the primary curve may have a
short term protective
effect on the unfused discs below the fusion area, possibly because they are
more symmetrically
loaded after surgery than before5,6. However it will stiffens a part of the
spine. Because of the long
fused thoracic segment, more load is centered on the lumbar segment of the
spine in spinal
movements, which may cause increased stress on zygapophysial joints and
intervertebral discs. This
may cause progression of degenerative osteoarthritis en degenerative disc
disease.
Furthermore, last year we examined the influence of the thoracic curve on the
pulmonary function
in patients with scoliosis. A meta-regression analysis showed that pulmonary
function (FEV1 and
FVC) in children and adolescents decreases with 1% per 2.5 to 3 degrees
increase of the Cobb
angle. Information on the long-term outcomes of the influence of scoliosis on
pulmonary function
is scarse, therefor we would like to re-do the spirometry to compare the
outcomes with the
spirometry during childhood.
Study objective
Our overall aim of the our project is to evaluate the long-term treatment
effects of bracing and
surgery in patients with adolescent idiopathic scoliosis, with a minimum 25
years follow-up.
Secondly, to determine clinical and/or radiological predictors to predict curve
progression.
1) What is the prevalence and degree of osteoarthritis and degenerative disc
disease in the lumbar
spine using radiographical imaging (i.d. Radiography and MRI)?
2) Is there a relation between these radiological findings and long-term
clinical outcomes (e.g.
backpain, quality of life) in these patient group?
Study design
The study is cross-sectional cohort study and enrolls scoliosis and control
patients. It will be
performed at the department of Orthopedics of the OLVG in Amsterdam. Patients
meeting the
inclusion and exclusion criteria will be selected from the OLVG scoliosis
database. Patients will be
contacted by telephone. After providing them with information on the study,
patients will be asked
if they are willing to participate after 2 weeks of consideration time. If a
patient gives approval, a
patient information letter and an informed consent form will be send to them.
After completing the
informed consent, the X-ray of their full spine and MRI scan of their lumbar
spine will be scheduled.
After the scan, the patients will be contacted by phone to discuss the outcome
of their scans.
In accordance with our research protocol, we will inquire whether patients have
undergone spinal radiography within the past five years prior to obtaining a
new radiograph. In the event that such a radiograph exists, we will seek
consent to retrieve and utilize these images for our research purposes,
particularly in cases where the radiograph was conducted at a different medical
facility.
Study burden and risks
For the study, the patient have to come once to the hospital. During this visit
two X-rays and one
MRI of the lower back will be taken. Thereby, a spirometry will be performed.
The patient*s burden from the study consists of one extra visits of 2,5 hours
to the OLVG hospital. It involves a standard anterior-posterior & lateral
radiographs and an MRI scan of the lumbar spine. The patient*s burden from the
study consists of one visit to the OLVG hospital. After analyzing the images,
the patients will be contacted by phone to discuss the outcome of their scans.
The questionnaires are already completed as part of a previous BASIS study in
OLVG hospital.
There are no risks associated with the MRI scan of the lumbar spine.
The risk of the single upright AP and lateral radiograph of the lumbar spine
will be limited. The effective radiation dose for a AP Lower Back image is 680
µSv.32 The additional annual radiation dose is limited if the natural annual
exposure of 2 mSv is considered and will do the patient no harm.33 The
International Commission on Radiological Protection categorizes the
corresponding level of risk qualitative due to radiation as *low* with a
quantitative risk of about 1 in 10.000 or less.
Radiation safety measures, such as using appropriate lead shielding and
minimizing the number of X-ray images taken, are employed to keep the radiation
dose as low as reasonably achievable (ALARA principle). Additionally,
healthcare providers follow specific protocols and equipment standards to
ensure that radiation doses are within safe limits.
Overall, a single X-ray of the spine in the AP and Sagittal views is generally
considered to be safe and compliant with Dutch laws and regulations on medical
radiation exposure. As with any medical procedure, healthcare providers
prioritize patient safety and ensure that radiation doses are kept as low as
reasonably achievable while providing valuable diagnostic insights
The risk associated with a MRI (Magnetic Resonance Imaging) scan of the lumbar
spine is generally considered to be very low. MRI uses a powerful magnetic
field and radio waves to create detailed images of the internal structures of
the body, including the spine. Unlike other imaging techniques that use
ionizing radiation (such as X-rays or CT scans), MRI does not expose the
patient to ionizing radiation, which is a significant advantage in terms of
safety. There are some considerations to keep in mind:
- Claustrophobia: Some individuals may experience claustrophobia (fear of
enclosed spaces) while inside the MRI machine, which can lead to discomfort or
anxiety during the procedure.
- Metallic objects: MRI uses a strong magnetic field, and therefore, it is
essential to remove all metallic objects from the body, including jewelry,
watches, and certain medical implants or devices, as they can be attracted to
the magnet or cause interference with the scan.
Oosterpark 9
Amsterdam 1091 AC
NL
Oosterpark 9
Amsterdam 1091 AC
NL
Listed location countries
Age
Inclusion criteria
For all patients
• Patients with adolescent idiopathic scoliosis
• Lenke type 1 scoliosis
• at least 25 years skeletal matureGroup 1
• Not treated surgicallyGroup 3
• Curve size matching curve size of group 1 before operation
• Not treated surgically
Exclusion criteria
• Inadequate knowledge of Dutch language
• Other forms of scoliosis (e.g. neuromuscular or congenital scoliosis)
• Inability to undergo an MRI scan (claustrophobia, pacemaker, etc)
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 | NL59162.100.17 |