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

Last updated: February 9, 2026
Sponsor: Azienda Usl di Bologna
Overall Status: Completed

Phase

N/A

Condition

Spinal Stenosis

Spondylolisthesis

Treatment

microsurgical decompression

decompression and instrumented fusion

Clinical Study ID

NCT06335511
631-2021-OSS-AUSLBO
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • degenerative lumbar stenosis caused by bone hypertrophy, osteoarthritis of facetjoints, ligamentous hypertrophy, disc protrusion

  • midsagittal spinal canal diameter of 12 mm or less

  • no radiological signs of instability, i.e. pathological motion on preoperativedynamic lumbar X-ray

  • ongoing symptoms for a minimum of 12 weeks with no improvement to conservativetreatment

  • eligibility for decompression alone (MiD) or decompression and fusion (MiD+F)

Exclusion

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)

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: microsurgical decompression
Phase:
Study Start date:
October 10, 2022
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • IRCCS Istituto Ortopedico Rizzolo

    Bologna 3181928, Bologna 40136
    Italy

    Site Not Available

  • IRCCS Istituto delle Scienze Neurologiche di Bologna

    Bologna 3181928, Bologna 40139
    Italy

    Site Not Available

  • IRCCS Istituto Ortopedico Rizzolo

    Bologna, 40136
    Italy

    Site Not Available

  • IRCCS Istituto delle Scienze Neurologiche di Bologna

    Bologna, 40139
    Italy

    Site Not Available

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