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New treatment option for Lumbar Spinal Stenosis
Official title Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis
ClinicalTrials.gov ID: NCT05273879
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75
You may be able to join 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 likely can't join 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Moscow, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.