Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT04893720
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2021-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration
Sponsor:
Military University Hospital, Prague
Organization:
Study Overview
Official Title:
The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the present study is to find out whether fusion of multilevel SPECT/CT positive lumbar degeneration leads to a significant improvement of pain and disability.
Detailed Description:
Chronic back pain (CBP) is a very common clinical problem. It is dominantly caused by degenerative changes, while specific causes such as tumor, trauma or inflammatory conditions are relatively rare. Back pain may be a concomitant symptom of lumbar disc herniation or spinal canal stenosis and is a typical symptom of spondylolisthesis. Magnetic resonance imaging (MRI) plays a key role in the diagnosis, showing in detail the soft structures, vertebral bodies (Modic changes, MC) or signs of facet arthropathy. On the other hand, it also proves a number of clinically silent findings. Degenerative disc disease (DDD) or facet osteoarthritis are most often considered to be a pain generator. The problem, however, is that both entities are very common in the general population without a painful correlate, and there is still controversy in the literature about their role in the genesis of CBP.
Radionuclide bone scintigraphy with single photon emission computed tomography (SPECT) provides functional imaging and is used to detect microcalcification due to increased osteoblastic activity. In the absence of other pathology the foci of increased osteoblastic activity reflex areas of mechanical stress and degenerative change in the skeleton. There is growing evidence about the relationship between DDD, facet arthropathy, and SPECT positivity. Although these findings have been recently confirmed by surgical studies, the evidence about the effect of surgical treatment of SPECT positive lumbar degeneration is still weak due to the small number of operated patients.
The aim of the present study is to define a possible correlation between degenerative changes of the lumbar spine and positivity on SPECT/CT imaging. Patients with multilevel SPECT+ DDD or facet arthropathy will undergo spinal fusion of the involved segments. Postoperative improvement will be measured by ODI (Oswestry Disability Index) and pain VAS (Visual Analogue Scale) in 6 and 24 months follow-up period.
Radionuclide bone scintigraphy with single photon emission computed tomography (SPECT) provides functional imaging and is used to detect microcalcification due to increased osteoblastic activity. In the absence of other pathology the foci of increased osteoblastic activity reflex areas of mechanical stress and degenerative change in the skeleton. There is growing evidence about the relationship between DDD, facet arthropathy, and SPECT positivity. Although these findings have been recently confirmed by surgical studies, the evidence about the effect of surgical treatment of SPECT positive lumbar degeneration is still weak due to the small number of operated patients.
The aim of the present study is to define a possible correlation between degenerative changes of the lumbar spine and positivity on SPECT/CT imaging. Patients with multilevel SPECT+ DDD or facet arthropathy will undergo spinal fusion of the involved segments. Postoperative improvement will be measured by ODI (Oswestry Disability Index) and pain VAS (Visual Analogue Scale) in 6 and 24 months follow-up period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: