Primary objective: We aim to examine whether the Cobb angle measurements are similar on a full spine x-ray compared to a targeted x-ray, following traumatic spinal injury in patients >55 years of age, after 3 and 12 months of follow-up.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cobb angle measured on full spine x-ray, from the superior endplate of the
adjacent cranial vertebral body to the inferior endplate of the adjacent caudal
body (bisegmental angle);
Cobb angle measured on targeted x-ray, from the superior endplate of the
adjacent cranial vertebral body to the inferior endplate of the adjacent caudal
body (bisegmental angle);
Wedge angle measured on full spine x-ray, measuring from the superior endplate
to the inferior of the injured vertebra.
Wedge angle measured on targeted x-ray, measuring from the superior endplate to
the inferior of the injured vertebra.
Secondary outcome
Date of trauma, duration of follow-up, type and region of fracture, (in case of
multitrauma: injury severity score (ISS)).
Background summary
In recent years there has been an increasing interest in the understanding and
prediction of global spinal balance in patients presenting with a vertebral
fracture. Especially in the aged patient, spinal balance may be impaired by
additional degenerative changes, decreased bone quality, or postural
abnormalities. Age is known to play a role in Spinal Posttraumatic Deformity
(SPTD). A vertebral fracture in older patients can lead to an anterior
displacement of the gravity mass and requires compensatory mechanisms from the
hips, lower extremities and cervical spine in order to recentralize the center
of gravity. These compensatory mechanisms, together with the unbalanced state
of the spine and the associated biomechanical changes in loading pattern, are
frequently accompanied by pain and physical impairment. The increased age of
these patients, and thus the increased predisposition to balance problems, has
led to a more frequent use of full-spine x-rays during follow-up in addition
to the targeted x-rays of the thoracic or lumbar spine.
Despite the benefits of this additional imaging, patients are often twice
exposed to radiation during the same follow-up moment. The radiation exposure
of a an AP and lateral x-ray of the lumbar- and thoracic spine is 1,5 mSv and 1
mSv resp. The radiation exposure of a full-spine series is 2.7 mSv . In
perspective, the average Dutch person is subjected to 2.9 mSv per year (of
which 1.24 mSv due to medical diagnostics). To avoid double radiation exposure,
it would be desirable to perform all measurements on the full spine radiograph.
To date, there has been no evidence of the reliability of measuring the Cobb
angle on a full spine radiograph. The purpose of this study is to compare
measurements of vertebral fractures on a focused X-ray to the same measurements
on a full-spine X-ray
Study objective
Primary objective: We aim to examine whether the Cobb angle measurements are
similar on a full spine x-ray compared to a targeted x-ray, following traumatic
spinal injury in patients >55 years of age, after 3 and 12 months of
follow-up.
Study design
This study will concern a single-center prospective design, the cohort will
consist of patients (>=55 years), presenting with a spinal fracture between
02.2022 and 31-12-2022. Data will be gathered from a single hospital
(Diakonessenhuis, Utrecht). Patients eligible for inclusion will receive an
information letter and an informed consent letter and a full-spine x-ray will
be made at 3- and 12 months of follow-up duration, in addition to the targeted
X-ray.
Study burden and risks
This study is prospective in nature. We will ask patients for informed consent
at presentation to the outpatient clinic. After 3- and 12 months of follow up
the patients will undergo a targeted X-rays and full spine x-rays. The location
of the targeted x-rays will depend on the location of the fracture in the
spine. A lumbar spine x-ray will be made for a lumbar spine fracture, and a
thoracic spine x-ray will be made for a thoracic spine fracture. The cobb
angles will be measured on both the full-spine and the targeted x-rays, and
compared to each other.
The radiation exposure of a an AP and lateral x-ray of the lumbar- and
thoracic spine is 1,5 mSv and 1 mSv resp. The radiation exposure of a
full-spine series is 2.7 mSv . In perspective, the average Dutch person is
subjected to 2.9 mSv per year (of which 1.24 mSv due to medical diagnostics).
To avoid double radiation exposure, it would be desirable to perform all
measurements on the full spine radiograph.
Bosboomstraat 1
Utrecht 3582KE
NL
Bosboomstraat 1
Utrecht 3582KE
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Adult (>=55 years at time of trauma)
- Traumatic spinal fracture of the thoracic or lumbar spine
- Treated between the date of approval from the METC, aimed at 01.02.2022 and
31-12-2022. at the Diakonessenhuis,
- ASIA C, D or E
- Capable of understanding the Dutch language and capable of filling out the
questionnaires.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study: - Oncological spinal fracture - ASIA A and B
- Non-recovered neuro-trauma - Polytrauma with invalidity not caused by spinal
fracture (ISS >15)
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 | NL80133.100.22 |