Status:
RECRUITING
Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis
Lead Sponsor:
Sklifosovsky Institute of Emergency Care
Collaborating Sponsors:
Pirogov National Medical Surgical Center
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Conditions:
Lumbar Spinal Stenosis
Spinal Stenosis
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
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 surg...
Detailed Description
The necessity of spinal segment fusion after decompression is one of the most controversial and unresolved issues in single-level lumbar spinal stenosis surgery. To date, only one trial carried out 15...
Eligibility Criteria
Inclusion
- age of patients from 45 to 75 years;
- stenosis C or D according to Shizas et al. according to MRI at the level of L2-L3, L3-L4, L4-L5 or L5-S1;
- clinical manifestations of lumbar stenosis (neurogenic claudication syndrome and/or radiculopathy);
- lack of effect from conservative therapy within 3 months;
- Informed consent to take part in the study.
Exclusion
- spondylolisthesis more than 3 mm;
- spinal instability according to functional radiography;
- sagittal imbalance (type 4 according to C. Barrey);
- bone density of the vertebrae at the level of the operation is less than 100 HU;
- clinically significant spinal stenosis at 2 or more levels;
- previously performed surgeries on the spine;
- risk of anesthesia 4 or 5 according to ASA;
- inability to take part in control examinations within 2 years after the operation;
- participation in other clinical trials related to surgical or conservative treatment of diseases of the spine.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05273879
Start Date
April 1 2022
End Date
December 30 2026
Last Update
December 18 2025
Active Locations (2)
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1
Pirogov National Medical and Surgical Center
Moscow, Moscow, Russia, 105203
2
Sklifosovsky Research Institute for Emergency Medicine
Moscow, Moscow, Russia, 107045