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

Launched by UNIVERSITY OF ROMA LA SAPIENZA · Sep 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for people suffering from lumbar spinal stenosis, a condition that causes narrowing of the spinal canal, leading to pain and discomfort, especially in the lower back and legs. The goal is to compare the effects of a minimally invasive procedure called percutaneous interspinous spacer placement with traditional surgical methods. Many patients who undergo surgery for spinal stenosis find that they are not satisfied with the results, so this trial aims to see if the non-surgical option can provide effective relief.

To be eligible for the trial, participants must be between 50 and 85 years old and have specific symptoms indicating lumbar spinal stenosis, such as pain in the legs when walking. They also need to have an MRI confirming the diagnosis. However, those with certain other health conditions, previous spinal surgeries, or significant spine deformities cannot participate. If you decide to join, you will receive the treatment being studied and will be monitored closely to see how well it works for managing your symptoms. This is an exciting opportunity to help advance treatment options for spinal stenosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 50-85 years.
• • 2. Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) indicating and motivating surgery. Numeric Rating Scale in lower limbs ≥3.
• • 3. MRI with finding of lumbar spinal stenosis at 1-3 lumbar levels. Dural sac area ≤75 mm2 or degree of stenosis C or D according to Schizas's classification.34
• • 4. The patient has given oral and written informed consent to participate.
• Exclusion Criteria:
• • 1. Degenerative deformity with Cobb angle \>20°.
• • 2. Symptomatic osteoarthritis in the lower limbs that affects and limits the patient's function.
• • 3. Arterial insufficiency (claudication intermittent).
• • 4. Former lumbar surgery other than disc hernia.
• • 5. Conditions that affect the spine, such as ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis, spondylodiscitis/infections, malignancy and neurological diseases.
• • 6. Heart and lung diseases presenting a significant risk for surgery or making it impossible for the patient to take part in a percutaneous arm of treatment (American Society of Anesthesiologists (ASA) score \>3).
• • 7. Polyneuropathies.
• • 8. Psychological factors rendering the patient incapable of inclusion in the trial (eg, drug addiction, dementia).