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NCT Number: NCT07139938

Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression

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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Key information

Conditions

LUMBAR STENOSIS Constriction, Pathologic Degeneration Lumbar Spine Lumbar Decompression Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sagittal Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Burdenko Neurosurgery Institute, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Non-Inclusion Criteria:

  • 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.)

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline in lumbar balance parameters

    Time frame: 3 months postoperatively

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

Secondary outcomes

  1. Change from baseline in lumbar balance parameters

    Time frame: 12 months postoperatively

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

  2. Change from baseline in lumbar balance parameters

    Time frame: 3 months and 12 months postoperatively

    To observe the change from baseline in full balance integrated index by full body X-Ray

  3. Change from baseline in lumbar balance parameters

    Time frame: 3 months and 12 months postoperatively

    To observe the change from baseline in lumbar lordosis (L1-S1) by full body X-Ray, in degrees

  4. Change from baseline in lumbar balance parameters

    Time frame: 3 months and 12 months postoperatively

    To observe the change from baseline in low lumbar lordosis (L4-S1) by full body X-Ray, in degrees

  5. Change from baseline in lumbar balance parameters

    Time frame: 3 months and 12 months postoperatively

    To observe the change from baseline in segmental lordosis at operated level by full body X-Ray, in degrees

  6. Change in the cross-sectional area of the dural sac, mm2

    Time frame: 3 months after surgery

    To observe the change in the cross-sectional area of the dural sac at operated lumbar level by MRI

  7. Change from baseline in Oswestry Disability Index

    Time frame: 3 months and 12 months postoperatively

    To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms (min - 0 - the best result, patient is active; max - 50 - the worst result, patient is not physically active

  8. Change from baseline in Numeric Pain Rating Scale

    Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively

    To observe the change of Numeric Pain Rating Scale as compared to baseline through follow-up terms (0 - no pain, 10 - unbearable pain)

  9. Change from baseline in Neuropathic Pain 4 Questions

    Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively

    To observe the change of Neuropathic Pain 4 Questions as compared to baseline through follow-up terms. If the total score is more than 4, the pain is neuropathic.

  10. Change from baseline in The Health Transition Item from SF-36

    Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively

    To observe the The Health Transition Item as compared to baseline through follow-up terms (Patient's answers range from 2 - ''Much Better,'' 1 -''Somewhat Better,'' 0 - ''About the Same,'' -1 - ''Somewhat Worse,'' to -2 - ''Much Worse.'')

  11. Change from baseline in posture alignment

    Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively

    To observe the patient's self-assessment of posture changes as compared to baseline (Patient asked: "How has your posture changed since the surgery?" 1 - better, 0 - unchanged (don't know), -1 - worse

  12. Adverse Events

    Time frame: during study, an average of 12 months

    Document Adverse Events (incl. adverse events related to device) occurrence throughout the study

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksandr Krutko, MD, PhD

CONTACT

[email protected]

+7 495 744 40 11

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Burdenko Neurosurgery Institute
  • Pirogov National Medical Surgical Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 24, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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