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
University of Roma La Sapienza
200 participants
Sep 1, 2024
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
Inclusion Criteria4
- Age 50-85 years.
- Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) indicating and motivating surgery. Numeric Rating Scale in lower limbs ≥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
- The patient has given oral and written informed consent to participate.
Exclusion Criteria8
- Degenerative deformity with Cobb angle \>20°.
- Symptomatic osteoarthritis in the lower limbs that affects and limits the patient's function.
- Arterial insufficiency (claudication intermittent).
- Former lumbar surgery other than disc hernia.
- Conditions that affect the spine, such as ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis, spondylodiscitis/infections, malignancy and neurological diseases.
- 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).
- Polyneuropathies.
- Psychological factors rendering the patient incapable of inclusion in the trial (eg, drug addiction, dementia).
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Interventions
Surgery with decompression. Central decompression of the stenotic segment with undercutting of the lateral recesses.
percutaneous image guided outpatient procedure that enables interspinous spacer insertion and fusion
Locations(1)
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NCT05527145