RecruitingNot ApplicableNCT05527145

Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial

Treatment of Spinal Stenosis and Spolilolisthesis With Percutaneous Interspinous Spacers. A Phase III Trial


Sponsor

University of Roma La Sapienza

Enrollment

200 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Symptomatic lumbar spinal stenosis is the most common indication for spinal surgery. However, more than one-third of the patients undergoing surgery for lumbar stenosis report dissatisfaction with the results. On the other hand, conservative treatment has shown positive results in some cases. This trial will compare the outcomes of surgical versus non-surgical treatment for lumbar stenosis.


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a minimally invasive device called a percutaneous interspinous spacer for people who have lumbar spinal stenosis (narrowing of the spinal canal in the lower back) with or without listhesis (slippage of vertebrae). These conditions can cause leg pain and cramping when walking. The device is placed between the spine's bony protrusions without major surgery, and this study compares it to standard surgical treatment. You may be eligible if... - You are between 50 and 85 years old - You have been diagnosed with lumbar spinal stenosis confirmed by MRI - You experience leg pain or cramping when walking (pseudoclaudication) with a pain score of 3 or more out of 10 - Stenosis is present at 1 to 3 lumbar levels You may NOT be eligible if... - You have significant spinal deformity (Cobb angle greater than 20 degrees) - You have symptomatic arthritis in your legs that limits your movement - You have poor blood flow in your legs (arterial insufficiency) - You have had previous lumbar spine surgery (other than for a disc hernia) - You have conditions affecting the spine such as ankylosing spondylitis, cancer, or infections - You have serious heart or lung disease (ASA score greater than 3) - You have polyneuropathy - You have psychological conditions such as dementia or drug addiction that prevent study participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMinimally invasive surgery

Surgery with decompression. Central decompression of the stenotic segment with undercutting of the lateral recesses.

PROCEDUREPercutaneous Spacer

percutaneous image guided outpatient procedure that enables interspinous spacer insertion and fusion


Locations(1)

Sapienza University of Rome, Policlinico Umberto I Hospital

Rome, Italy

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NCT05527145


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