Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis

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

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.

Study Overview

• Status: Completed
• Conditions: Intervertebral Disc Degeneration; Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: lumbar fusion

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russia
  • Moscow, Russia, 127299
    • Priorov National Medical Research Center of Traumatology and Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 40-75 years;
2. 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;
3. Symptoms persisting for at least three months prior to surgery;
4. Given written Informed Consent Form;
5. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements;
6. Oswestry Disability Index score of at least 40/100 at baseline;

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Minimally invasive TLIF; Patients will undergo a single level decompression and fusion using a minimally invasive technique. Followed posterior screw fixation is mandatory.	Procedure: lumbar fusion; Transforaminal Lumbar Interbody Fusion will be performed using minimally invasive approach or traditional open technique.
Other: Open TLIF; Patients will undergo a single level decompression and fusion using an open traditional technique. Followed posterior screw fixation is mandatory.	Procedure: lumbar fusion; Transforaminal Lumbar Interbody Fusion will be performed using minimally invasive approach or traditional open technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Oswestry Disability Index (ODI)	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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Oswestry Disability Index (ODI)	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	Through 2 years
Change from baseline in Numeric Pain Rating Score (NPRS)	To observe the change of NPRS as compared to baseline through follow-up terms (0 - no pain, 10 - unbearable pain)	Through 2 years
Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D).	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.	Through 2 years
Change from baseline in Douleur Neuropathique 4 (DN4)	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	Through 2 years
Change from baseline in The Health Transition Item from SF-36 (HTI Item)	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.''	Through 2 years
Change from baseline in Clinical Global Impression Of Change (CGIC) scale	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.	Through 2 years
Cost-effectiveness	Total cost of surgical procedure (implanted system, the salary for surgery team) and the cost of patient's staying at the clinic before discharge.	14th day of hospital stay
Fusion rate success	Interbody fusion rate on CT based on Tan grades	12 months and 24 months post op
Surgery duration	Surgery duration, min	Day of surgery
Reoperations rate	Incidence of reoperations	Through 2 years
Pelvic Incidence	To observe the sagittal balance parameter - Pelvic Incidence - by sagittal scans of spine by X-Ray, in degrees	Through 2 years
Change from baseline in Pelvic Tilt	To observe the sagittal balance parameter - Pelvic Tilt - by sagittal scans of spine by X-Ray compared to baseline, in degrees	Through 2 years
Change from baseline in Global Lordosis Angle	To observe the sagittal balance parameter - Global Lordosis Angle - by sagittal scans of spine by X-Ray compared to baseline, in degrees	Through 2 years
Change from baseline in Segmental Lordosis	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	Through 2 years
Change from baseline in Sagittal Vertical Axis	To observe the sagittal balance parameter - Sagittal Vertical Axis - by sagittal scans of spine by X-Ray compared to baseline, in mm	Through 2 years
Adverse Events	Document Adverse Events (incl. adverse events related to device) occurrence throughout the study	Through 2 years

Collaborators and Investigators

• Sponsor: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics

Publications and helpful links

General Publications

• Leonova ON, Cherepanov EA, Krutko AV. MIS-TLIF versus O-TLIF for single-level degenerative stenosis: study protocol for randomised controlled trial. BMJ Open. 2021 Mar 5;11(3):e041134. doi: 10.1136/bmjopen-2020-041134.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): February 27, 2024
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: October 10, 2020
• First Submitted That Met QC Criteria: October 17, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Stenosis; Intervertebral Disc Degeneration
• Other Study ID Numbers: NS02-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data are available upon reasonable request. Please contact the corresponding author for detail.
• IPD Sharing Time Frame: During the study conducting and during 5 years after
• IPD Sharing Access Criteria: The approval of institutional review board will be necessary
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No