Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression

NCT07139938 | Recruiting

• 1 other identifier: NS12-05
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

LUMBAR STENOSIS; Sagittal Imbalance; Degeneration Lumbar Spine; Lumbar Decompression

Keywords

lumbar stenosis; sagittal imbalance; lumbar decompression

Outcome Measures

Primary Outcomes (1)

• Change from baseline in lumbar balance parameters

  To observe the change from baseline in sagittal vertical axis by full body X-Ray, in mm

  3 months postoperatively

Secondary Outcomes (12)

• Change from baseline in lumbar balance parameters

  12 months postoperatively

• Change from baseline in lumbar balance parameters

  3 months and 12 months postoperatively

• Change from baseline in lumbar balance parameters

  3 months and 12 months postoperatively

• Change from baseline in lumbar balance parameters

  3 months and 12 months postoperatively

• Change from baseline in lumbar balance parameters

  3 months and 12 months postoperatively

Study Arms (1)

Cohort

OTHER

Isolated lumbar decompression

Procedure: Isolated lumbar decomression

Interventions

Isolated lumbar decomression 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.

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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;

You may not qualify if:

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

Sponsors & Collaborators

• N.N. Priorov National Medical Research Center of Traumatology and Orthopedics: lead
• Burdenko Neurosurgery Institute: collaborator
• Pirogov National Medical Surgical Center: collaborator

Study Sites (3)

Pirogov National Medical Surgical Center

Moscow, 105203, Russia

RECRUITING

Burdenko Neurosurgery Institute

Moscow, 125047, Russia

RECRUITING

Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, 127299, Russia

RECRUITING

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aleksandr Krutko, MD, PhD

CONTACT

+7 495 744 40 11; ortho-ped@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 24, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): October 6, 2026
• Study Completion (Estimated): October 6, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

RU (3)