The primary aim of this pilot study is to evaluate whether adding BoneMRI to the current workflow, which consists of a standard MRI scan and only on indication an X-ray or CT scan, improves the neurosurgeon satisfaction and certainty in the surgery…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the satisfaction and certainty of the neurosurgeon in
the surgery planning measured with a 10-point Likert scale before viewing the
BoneMRI preoperative, after viewing the BoneMRI preoperative and postoperative.
Comparison of Likert-scores of part A (T0) of the questionnaire to part B (T1)
and part A (T0) to part C (T2) will be performed. For the questions of part B
and C only pertaining to the BoneMRI, the median or mean Likert scores of each
question, depending on normality of the data, is evaluated.
Secondary outcome
The secondary outcome is the diagnostic accuracy of BoneMRI in visualization of
pathoanatomic aspects related to radiculopathy compared to the current workflow
(MRI, X-ray and CT scan if available) as assessed by the neurosurgeon with
perioperative findings serving as reference standard.
Background summary
Magnetic Resonance Imaging (MRI) is frequently used in the evaluation of
symptoms referring to diseases of the cervical spine, such as radiculopathy and
myelopathy. MRI offers excellent soft-tissue visualization without the use of
ionizing radiation. CT can be very useful as an adjunct to MRI to assess
osseous involvement of disease. International literature has not yet reached
consensus about the best diagnostic strategy in osseous conditions of the
cervical spine. Recently, Bone MRI was developed, a quantitative MRI technique
by MRIGuidance BV©, which is based on a multiple gradient-echo sequence and a
machine learning processing pipeline and is capable of generating CT-like
quantitative bone MRI images. The use of Bone MRI is currently investigated in
multiple musculoskeletal studies. If successful, future patients can benefit
from better diagnostic techniques, without the potential hazards of ionizing
radiation.
Study objective
The primary aim of this pilot study is to evaluate whether adding BoneMRI to
the current workflow, which consists of a standard MRI scan and only on
indication an X-ray or CT scan, improves the neurosurgeon satisfaction and
certainty in the surgery planning compared to the current workflow without
BoneMRI in patients with cervical radiculopathy and/or -myelopathy eligible for
surgery.
Study design
This study is a prospective longitudinal, single center, clinical pilot study.
All patients with cervical radiculopathy and/or myelopathy referred to the
neurosurgery department of the Isala hospital in Zwolle, the Netherlands, who
are on the waiting list for cervical spine surgery and that gave informed
consent on participation in this study. The patients will undergo an extra MRI
prior to admission. This extra MRI is viewed by the neurosurgeon, who will
complete a questionnaire.
Study burden and risks
The patient does not benefit from participating in this study and will receive
routine care. For research purposes an additional MRI scan of the cervical
spine will be obtained for each patient. Patients are not exposed to ionizing
radiation and do not make an additional hospital visit. The surgery will be
performed according to the conventional protocols and imaging, without the
BoneMRI.
Thus the burden exists of being present in the hospital 2 hours prior to the
admission, of which 4 minutes lying still for for the scan.
This study may contribute to a lower radiation dose in future patients: if Bone
MRI images are sufficient for assessing osseous structures of the cervical
spine, an additional CT scan will become redundant.
Dr. van Heesweg 2
Zwolle 8025 AB
NL
Dr. van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
• Patients with the clinical diagnosis of cervical radiculopathy and/or
myelopathy;
• Received a MRI cervical spine;
• Eligible for cervical spine surgery based on neurosurgical evaluation of the
clinical symptoms and imaging.
Exclusion criteria
• History of osteosynthesis in the spine
• Previous participation in the study;
• Malignancy.
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 | NL74463.075.20 |