Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis

NCT04594980 | Completed

• 1 other identifier: NS02-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intervertebral Disc Degeneration; Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Change from baseline in Oswestry Disability Index (ODI)

  Through 2 years

• Change from baseline in Numeric Pain Rating Score (NPRS)

  Through 2 years

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

  Through 2 years

• Change from baseline in Douleur Neuropathique 4 (DN4)

  Through 2 years

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

  Through 2 years

Study Arms (2)

Minimally invasive TLIF

OTHER

Patients will undergo a single level decompression and fusion using a minimally invasive technique. Followed posterior screw fixation is mandatory.

Procedure: lumbar fusion

Open TLIF

OTHER

Patients will undergo a single level decompression and fusion using an open traditional technique. Followed posterior screw fixation is mandatory.

Procedure: lumbar fusion

Interventions

lumbar fusion PROCEDURE

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

Minimally invasive TLIF; Open TLIF

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, 127299, Russia

Location

Related Publications (1)

• 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.

  PMID: 33674366 DERIVED

MeSH Terms

Conditions

Spinal Stenosis; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2020
• First Posted: October 20, 2020
• Study Start: January 20, 2022
• Primary Completion: February 27, 2024
• Study Completion: March 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: During the study conducting and during 5 years after
• Access Criteria: The approval of institutional review board will be necessary

Locations

RU (1)