Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-06

Study Completion Date

2027-10-06

Brief Summary

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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.

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Detailed Description

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Conditions

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LUMBAR STENOSIS Sagittal Imbalance Degeneration Lumbar Spine Lumbar Decompression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort

Isolated lumbar decompression

Group Type OTHER

Isolated lumbar decomression

Intervention Type PROCEDURE

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.

Interventions

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Isolated 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1\. Age 45 and over;
* 2\. 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;
* 3\. Planned isolated decompression of the spinal canal without implantation of any devices;
* 4\. Symptoms persisting for at least 3 months prior to surgery;
* 5\. Given written Informed Consent;
* 6\. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

* 1\. Prior any lumbar surgery;
* 2\. Scoliosis of any non-degenerative etiology (due to vertebral fractures, idiopathic, etc.);
* 3\. Degenerative scoliosis \> 20 degrees;
* 4\. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
* 5\. 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 Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No