RecruitingNot Applicable

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

Russia86 participantsStarted 2022-04-01

Plain-language 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.

Who can participate

Age range

45 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Oswestry Disability Index

Timeframe: 24 months

Trial details

NCT IDNCT05273879

SponsorSklifosovsky Institute of Emergency Care

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Ivan Lvov, MD, PhD

+79265760074 dr.speleolog@gmail.com

View on ClinicalTrials.gov More Lumbar Spinal Stenosis trials