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Completed

NCT Number: NCT04594980

Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis

The purpose of this study is to determine the effectiveness of minimally invasive decompression and fusion over the traditional open decompression and fusion in patients with single-level lumbar stenosis caused by degenerative spondylolisthesis. Postoperative follow-up will continue for 12 months. Сlinical, safety, radiological and cost-effectiveness endpoints will be evaluated.

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, 127299, Russia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 40-75 years;
  • Neurogenic claudication or bilateral radiculopathy caused by single level combination of degenerative stenosis and spondylolisthesis confirmed by MRI at one level L3-L4 or L4-L5 or L5-S1;
  • Symptoms persisting for at least three months prior to surgery;
  • Given written Informed Consent Form;
  • Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements;
  • Oswestry Disability Index score of at least 40/100 at baseline;

Exclusion criteria

  • Bilateral foraminal stenosis requiring surgical decompression on both sides;
  • Degenerative spondylolisthesis Type 2B, 3 subtypes by Gille;
  • More than one symptomatic level requiring multi-level surgical decompression and/or fusion;
  • Any condition that cannot be treated with mini-invasive unilateral decompression and fusion;
  • Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
  • Spondylolisthesis grade II or higher of any etiology;
  • Prior lumbar spinal fusion at any level;
  • Other non-degenerative spinal conditions that may have an impact on subject safety, wellbeing or the intent and conduct of the study;
  • History or presence of any other major neurological disease or condition that may interfere with the study assessments;
  • Severe arterial insufficiency of the legs or other peripheral vascular disease;
  • Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).

Treatment and study plan

Lumbar Fusion

Procedure

Transforaminal Lumbar Interbody Fusion will be performed using minimally invasive approach or traditional open technique.

Primary outcomes

  1. Change from baseline in Oswestry Disability Index (ODI)

    Time frame: 3 months

    To observe the change of ODI 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

Secondary outcomes

  1. Change from baseline in Oswestry Disability Index (ODI)

    Time frame: Through 2 years

    To observe the change of ODI 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

  2. Change from baseline in Numeric Pain Rating Score (NPRS)

    Time frame: Through 2 years

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

  3. Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D).

    Time frame: Through 2 years

    To observe the change of EQ-5D as compared to baseline through follow-up terms. It assesses 5 components related to aspects of life: mobility, self-care, activity in daily life, pain, anxiety or depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

  4. Change from baseline in Douleur Neuropathique 4 (DN4)

    Time frame: Through 2 years

    To observe the change of DN4 as compared to baseline through follow-up terms. The scale result ranges 0-10 points. The sum > 4 points indicates the neuropathic component of pain

  5. Change from baseline in The Health Transition Item from SF-36 (HTI Item)

    Time frame: Through 2 years

    To observe the change of HTI Item through follow-up terms. Patient's answers range from ''Much Better,'' ''Somewhat Better,'' ''About the Same,'' ''Somewhat Worse,'' to ''Much Worse.''

  6. Change from baseline in Clinical Global Impression Of Change (CGIC) scale

    Time frame: Through 2 years

    To observe the change of CGIC through follow-up terms. The answers range from "-2 Significantly worse compared to Baseline" to "+2 Significantly improved compared to Baseline". 7-points scale indicates the patient's condition assessed by physician.

  7. Cost-effectiveness

    Time frame: 14th day of hospital stay

    Total cost of surgical procedure (implanted system, the salary for surgery team) and the cost of patient's staying at the clinic before discharge.

  8. Fusion rate success

    Time frame: 12 months and 24 months post op

    Interbody fusion rate on CT based on Tan grades

  9. Surgery duration

    Time frame: Day of surgery

    Surgery duration, min

  10. Reoperations rate

    Time frame: Through 2 years

    Incidence of reoperations

  11. Pelvic Incidence

    Time frame: Through 2 years

    To observe the sagittal balance parameter - Pelvic Incidence - by sagittal scans of spine by X-Ray, in degrees

  12. Change from baseline in Pelvic Tilt

    Time frame: Through 2 years

    To observe the sagittal balance parameter - Pelvic Tilt - by sagittal scans of spine by X-Ray compared to baseline, in degrees

  13. Change from baseline in Global Lordosis Angle

    Time frame: Through 2 years

    To observe the sagittal balance parameter - Global Lordosis Angle - by sagittal scans of spine by X-Ray compared to baseline, in degrees

  14. Change from baseline in Segmental Lordosis

    Time frame: Through 2 years

    To observe the sagittal balance parameter - Segmental Lordosis (the angle of treated level) - by sagittal scans of spine by X-Ray compared to baseline, in degrees

  15. Change from baseline in Sagittal Vertical Axis

    Time frame: Through 2 years

    To observe the sagittal balance parameter - Sagittal Vertical Axis - by sagittal scans of spine by X-Ray compared to baseline, in mm

  16. Adverse Events

    Time frame: Through 2 years

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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

An Open-Label Randomized Controlled Study of the Efficacy of Surgical Treatment in Patients With Single Level Lumbar Spinal Stenosis Using Minimally Invasive Decompression and Fusion and Traditional Open

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Oct 20, 2020
Registry last updated
Mar 3, 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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