Image

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

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

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

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.

Eligibility

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)

Study details

Lumbar Spinal Stenosis, Degenerative Lumbar Spinal Stenosis

NCT06335511

Azienda Usl di Bologna

16 April 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.