Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis
Recruiting now · Not applicable
Conditions studied: Lumbar Spinal Stenosis, Spinal Stenosis, Spinal Fusion
In brief
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.
Key facts
- Study ID
- NCT05273879
- Run by
- Sklifosovsky Institute of Emergency Care
- People needed
- 86
- Starts
- 2022-04-01
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2025-12-18
Who can join
Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pirogov National Medical and Surgical Center — Moscow, Moscow, Russia (enrolling)
- Sklifosovsky Research Institute for Emergency Medicine — Moscow, Moscow, Russia (enrolling)
Full record on ClinicalTrials.gov
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