RecruitingNot ApplicableNCT07139938

Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression

Multicenter Study of Spontaneous Correction of Sagittal Imbalance After Isolated Decompression Surgery Without Corrective Fusion Procedure for Lumbar Spinal Stenosis

Sponsor

N.N. Priorov National Medical Research Center of Traumatology and Orthopedics

Enrollment

165 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

LUMBAR STENOSIS Sagittal Imbalance Degeneration Lumbar Spine Lumbar Decompression

Summary

Sagittal spinal imbalance may be caused by orthopedic problems, compression of the neural structures of the spinal canal, and pain syndrome (functional imbalance). Sagittal imbalance in combination with appropriate clinical symptoms may require surgical correction of the spine with fixation. However, in some cases, patients experience spontaneous correction of sagittal balance after isolated decompression without any correction or fusion. Therefore, it is necessary to clarify whether isolated decompression may cause spontaneous correction of sagittal imbalance in patients with degenerative lumbar stenosis.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

\. Age 45 and over;
\. Radicular leg pain and/or neurogenic claudication with/without back pain, caused by single- or multi-level degenerative lumbar stenosis with/without spodylolisthesis, confirmed by MRI;
\. Planned isolated decompression of the spinal canal without implantation of any devices;
\. Symptoms persisting for at least 3 months prior to surgery;
\. Given written Informed Consent;
\. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
\. Prior any lumbar surgery;
\. Scoliosis of any non-degenerative etiology (due to vertebral fractures, idiopathic, etc.);
\. Degenerative scoliosis \> 20 degrees;
\. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
\. Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study;

Exclusion Criteria2

\. Performed intraoperative discotomy;
\. Performed intraoperative iatrogenic instability of the lumbar segment (facetectomy, foraminotomy, etc.)

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Interventions

PROCEDUREIsolated lumbar decomression

All patients will undergo microsurgical decompression of stenosed neural structures of the lumbar canal at all clinically significant levels with saving the posterior spinal column (type of decompression may be as unilateral, bilateral, or bilateral from a unilateral approach (over-the-top)), including endoscopic decompression. Degenerative lumbar stenosis may be caused by thickened yellow and posterior longitudinal ligaments, facet joints hypertrophy, vertebral body osteophytes posteriorly, synovial (facet joints cysts) and disc cysts.