Spinal fusion for patients with multilevel lumbar degeneration
The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration
Military University Hospital, Prague · NCT04893720
This study is testing if spinal fusion surgery can help people with long-term lower back pain from multiple degenerative issues feel better and improve their daily activities.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Military University Hospital, Prague (other) |
| Locations | 2 sites (Prague and 1 other locations) |
| Trial ID | NCT04893720 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of spinal fusion in patients with chronic back pain associated with multilevel SPECT/CT positive lumbar degeneration. It focuses on individuals who have experienced lower back pain for over six months despite conservative treatment and have specific MRI findings indicating degenerative disc disease or facet arthropathy. The study will assess whether surgical intervention leads to significant improvements in pain and disability. By utilizing SPECT/CT imaging, the study seeks to correlate functional changes in the spine with clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals with chronic lower back pain lasting more than six months and showing specific degenerative changes on MRI and SPECT/CT.
Not a fit: Patients with other spinal pathologies, such as tumors or congenital defects, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from chronic back pain due to lumbar degeneration.
How similar studies have performed: Other studies have shown promising results in similar surgical approaches for degenerative spine conditions, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Lower back pain (in extension +/- pain in buttocks, groin, thigh) without radicular pain * Symptoms \> 6 months after the failure of conservative management in the primary care setting * MRI signs of degenerative disc disease or facet arthropathy * Two- or more levels of positivity on lumbar SPECT/CT Exclusion Criteria: * Other spinal pathology (tumors, congenital defects, spondylolysis, or spondylolisthesis) * Intolerance of SPECT examination * Pregnancy
Where this trial is running
Prague and 1 other locations
- Military University Hospital Prague — Prague, Czechia (RECRUITING)
- University Hospital, Motol — Prague, Czechia (RECRUITING)
Study contacts
- Study coordinator: Radek Kaiser
- Email: rkaiser@hotmail.cz
- Phone: +420607545132
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Degenerative Disc Disease, Back Pain Lower Back Chronic, Facet Joint Arthropathy, Facet Syndrome of Lumbar Spine