Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study

Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study

Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis.

Degenerative lumbar spine is the most common cause of chronic pain and disability with remarkable economic impact. Treatment begins with conservative options (physical combined with antalgic therapy) but often requires surgical treatment.

Two different groups of patients affected by symptomatic lumbar stenosis with no preoperative radiological signs of instability will be recruited in a prospective trial and proposed for surgery: microsurgical decompression (MiD) or decompression and instrumented fusion (MiD + F). Clinical and mechanical outcomes of two different treatments (MiD vs. MiD+F) will be compared.

An in-vitro biomechanical study will evaluate the biomechanical effect of the two surgical techniques.

The aim of this project is to obtain robust data for tailoring the surgical approach to patient individual characteristics and needs, to gain the best clinical evidence, and possibly reducing the overall costs of management of this disease.

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)