Actively Recruiting
Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis
Led by Sklifosovsky Institute of Emergency Care · Updated on 2025-12-18
86
Participants Needed
2
Research Sites
247 weeks
Total Duration
On this page
Sponsors
S
Sklifosovsky Institute of Emergency Care
Lead Sponsor
P
Pirogov National Medical Surgical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Long-term clinical results of two methods of surgical treatment (spinal decompression with or without fusion) in patients with single-level lumbar stenosis will be compared. A clear framework for surgical treatment methods and standardized postoperative rehabilitation treatment will be set to obtain the maximum homogeneity of the patient groups. This trial should provide the first level of evidence for the need for spinal fusion in patients with single-level lumbar stenosis, subject to the high homogeneous comparison groups. Additional results will allow comparing the economic aspects of different surgical treatments for 2 years after surgery.
CONDITIONS
Official Title
Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of patients from 45 to 75 years
- Stenosis grade C or D according to MRI at L2-L3, L3-L4, L4-L5, or L5-S1 levels
- Clinical symptoms of lumbar stenosis such as neurogenic claudication syndrome or radiculopathy
- No improvement after at least 3 months of conservative therapy
- Provided informed consent to participate in the study
You will not qualify if you...
- Spondylolisthesis greater than 3 mm
- Spinal instability shown by functional radiography
- Sagittal imbalance type 4 according to C. Barrey
- Bone density at the surgery level less than 100 Hounsfield units
- Significant spinal stenosis affecting two or more levels
- Previous spine surgeries
- Anesthesia risk classified as ASA 4 or 5
- Unable to attend control examinations for 2 years after surgery
- Participation in other clinical trials involving spine treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Pirogov National Medical and Surgical Center
Moscow, Moscow, Russia, 105203
Actively Recruiting
2
Sklifosovsky Research Institute for Emergency Medicine
Moscow, Moscow, Russia, 107045
Actively Recruiting
Research Team
I
Ivan Lvov, MD, PhD
CONTACT
A
Anton Kordonskiy, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here