NCT05527145 Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial
| NCT ID | NCT05527145 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Roma La Sapienza |
| Condition | Lumbar Spine Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-09 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-09 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05527145 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Lumbar Spine Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05527145 currently recruiting?
Yes, NCT05527145 is actively recruiting participants. Contact the research team at alessandro.napoli@uniroma1.it for enrollment information.
Where is the NCT05527145 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT05527145 clinical trial?
NCT05527145 is sponsored by University of Roma La Sapienza. The trial plans to enroll 200 participants.