Actively Recruiting
Treatment of Spinal Stenosis and Spondylolisthesis Using Percutaneous Interspinous Spacers Compared to Surgery
Led by University of Roma La Sapienza · Updated on 2024-02-12
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatment options for symptomatic lumbar spinal stenosis, a common reason for spinal surgery. This study compares surgical and non-surgical treatments to understand which method may lead to better patient outcomes. It focuses on patients aged 50 to 85 who experience symptoms that motivate surgery, aiming to improve satisfaction with treatment results. The trial randomly assigns 200 patients to one of two groups. One group receives surgery involving decompression of the nerve structures using open or minimally invasive techniques, with or without spinal fusion. The other group undergoes a non-surgical, image-guided procedure to insert a percutaneous interspinous spacer device combined with fusion. Both treatments are being studied to assess their effects on lumbar spinal stenosis. Participants will be followed for up to one year, with key evaluations including the Oswestry Disability Index at 26 and 52 weeks to measure disability related to back pain. Other assessments include quality of life surveys, pain ratings, walking ability assessments, nerve conduction studies, and electromyography to monitor nerve function. Patient-reported outcomes and safety will also be tracked throughout the study period to understand treatment impact.
CONDITIONS
Brief Title
Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 to 85 years
- Clinical symptoms of lumbar spinal stenosis causing leg pain with a Numeric Rating Scale score of 3 or higher
- MRI confirming lumbar spinal stenosis at 1 to 3 levels with specific findings
- Provided oral and written informed consent to participate
You will not qualify if you...
- Degenerative spinal deformity with Cobb angle greater than 20 degrees
- Symptomatic osteoarthritis in lower limbs affecting function
- Arterial insufficiency causing intermittent claudication
- Previous lumbar surgery other than disc herniation
- Spine conditions such as ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis, infections, malignancy, or neurological diseases
- Heart or lung diseases posing significant surgical risk or preventing participation in percutaneous treatment (ASA score above 3)
- Polyneuropathies
- Psychological conditions preventing study participation such as drug addiction or dementia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 52 weeks
Participants receive either minimally invasive surgery or percutaneous interspinous spacer insertion as part of their assigned treatment arm.
Trial Site Locations
Total: 1 location
1
Sapienza University of Rome, Policlinico Umberto I Hospital
Rome, Italy
Actively Recruiting
Research Team
A
Alessandro napoli, md, phd
S
silvia ciotti
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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