Clinical Trial

Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis

Recruiting
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-03-01; most recent amendment 2025-12-11.
Status change: Active, Not Recruiting → Recruiting 2025-12-11
Status change: Recruiting → Active, Not Recruiting 2024-04-16
Status change: Not Yet Recruiting → Recruiting 2022-04-07
Trial Details
NCT Number NCT05273879
Lead Sponsor Sklifosovsky Institute of Emergency Care
Collaborators: Pirogov National Medical Surgical Center, Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Conditions Lumbar Spinal Stenosis, Spinal Stenosis, Spinal Fusion
Enrollment 86 participants
Start Date 2022-04-01
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-18