NCT05273879 Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis
| NCT ID | NCT05273879 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sklifosovsky Institute of Emergency Care |
| Condition | Lumbar Spinal Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2026-12-30 |
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 86 participants in total. It began in 2022-04-01 with a primary completion date of 2026-12-30.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Andrey Grin, MD, PhD
STUDY CHAIR
Sklifosovsky Research Institute for Emergency Medicine
Frequently Asked Questions
Who can join the NCT05273879 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Lumbar Spinal Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05273879 currently recruiting?
Yes, NCT05273879 is actively recruiting participants. Contact the research team at dr.speleolog@gmail.com for enrollment information.
Where is the NCT05273879 trial being conducted?
This trial is being conducted at Moscow, Russia, Moscow, Russia.
Who is sponsoring the NCT05273879 clinical trial?
NCT05273879 is sponsored by Sklifosovsky Institute of Emergency Care. The principal investigator is Andrey Grin, MD, PhD at Sklifosovsky Research Institute for Emergency Medicine. The trial plans to enroll 86 participants.