Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgica
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 th
| Condition(s) | Lumbar Spine Degeneration, Lumbar Spine Instability, Lumbar Spondylolisthesis, Lumbar Spinal Stenosis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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, |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Lead sponsor | University of Roma La Sapienza |
| Locations | Rome, Italy |
| Start date | 2024-09 |
| NCT ID | NCT05527145 |
| Official listing | https://clinicaltrials.gov/study/NCT05527145 |