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

Azienda Usl di Bologna

Status

Completed

Conditions

Lumbar Spinal Stenosis

Degenerative Lumbar Spinal Stenosis

Treatments

Procedure: decompression and instrumented fusion

Procedure: microsurgical decompression

Study type

Observational

Funder types

Other

Identifiers

NCT06335511

631-2021-OSS-AUSLBO

Details and patient eligibility

About

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

Full description

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)