Comparing two surgical methods for lumbar degenerative disease
Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study
This study is testing which of two surgical methods for treating lumbar degenerative stenosis works better for patients by comparing their outcomes after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Usl di Bologna Government |
| Locations | 2 sites (Bologna and 1 other locations) |
| Trial ID | NCT06335511 on ClinicalTrials.gov |
What this trial studies
This study aims to identify clinical and biomechanical parameters that can predict outcomes for patients undergoing surgery for lumbar degenerative stenosis. It will recruit two groups of patients with symptomatic lumbar stenosis who will receive either microsurgical decompression or decompression with instrumented fusion. The clinical and mechanical outcomes of these two surgical approaches will be compared to determine the most effective treatment. Additionally, an in-vitro biomechanical study will assess the effects of both techniques, providing data to tailor surgical approaches to individual patient needs.
Who should consider this trial
Good fit: Ideal candidates are individuals with degenerative lumbar stenosis who have not responded to conservative treatment and meet specific radiological criteria.
Not a fit: Patients with congenital, traumatic, or neoplastic lumbar stenosis, or those who have had previous lumbar surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective surgical treatments for patients with lumbar degenerative disease.
How similar studies have performed: Other studies have explored similar surgical approaches, but this study aims to provide robust data specific to the comparison of these two techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * degenerative lumbar stenosis caused by bone hypertrophy, osteoarthritis of facet joints, ligamentous hypertrophy, disc protrusion * midsagittal spinal canal diameter of 12 mm or less * no radiological signs of instability, i.e. pathological motion on preoperative dynamic lumbar X-ray * ongoing symptoms for a minimum of 12 weeks with no improvement to conservative treatment * eligibility for decompression alone (MiD) or decompression and fusion (MiD+F) Exclusion Criteria: * congenital, traumatic, infectious and neoplastic lumbar stenosis, * spondylolisthesis (on static X-ray), lumbar scoliosis (Cobb\>10°), * previous lumbar surgery, other types of operations (endoscopic decompression, anterior interbody fusions, interspinous devices etc.). * patients with spine deformity requiring long fusion (i.e. \>=3 levels)
Where this trial is running
Bologna and 1 other locations
- IRCCS Istituto Ortopedico Rizzolo — Bologna, Italy (Recruiting)
- IRCCS Istituto delle Scienze Neurologiche di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Alfredo Conti, Prof. — IRCCS Istituto delle Scienze Neurologiche di Bologna
- Study coordinator: Alfredo Conti, Prof.
- Email: alfredo.conti2@unibo.it
- Phone: +393382131017
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.