Comparing two surgical methods for lumbar degenerative disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.