The SPINUS I Study: Spinal Fusion for a Single Level SPECT/CT Positive Lumbar Degenerative Disc Disease
Condition: Degenerative Disc Disease; Back Pain, Low
MeSH terms: Spinal Diseases; Intervertebral Disc Degeneration; Low Back Pain
Study type: Observational

Summary: 
      The aim of the present study is to find out whether fusion of a sinlge level SPECT/CT
      positive degenerative disc disease 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 a single level SPECT+
      DDD will undergo spinal fusion of the involved segment. Postoperative improvement will be
      measured by ODI (Oswestry Disability Index) and pain VAS (Visual Analogue Scale) in 6 and 24
      months follow-up period.
    

Intervention name(s): Lumbar fusion
Intervention type(s): Procedure
Intervention description(s): Transforaminal Lumbar Interbody Fusion of the SPECT/CT positive degenerative disc disease
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        An open prospective cohort study will be performed. Inclusion criteria will be: subjects
        between 18 and 75 years of age; both genders; with CBP and diagnosis of DDD or facet
        arthropathy on MRI and increased metabolic activity on bone SPECT/CT imaging in the same
        level(s) who are undergoing open lumbar interbody fusion. New MRI of the lumbar spine and
        SPECT/CT will be performed 2 years after the surgical procedure. The patients will complete
        ODI and VAS questionnaires before surgery and at 6- and 24-months follow-up visits. All
        patients will sign an informed consent form.