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Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis

Primary Purpose

Lumbar Spinal Stenosis, Intervertebral Disc Degeneration

Status

Recruiting

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

lumbar fusion

About this trial

This is an interventional diagnostic trial for Lumbar Spinal Stenosis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Priorov National Medical Research Center of Traumatology and OrthopedicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Minimally invasive TLIF

Open TLIF

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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)

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.

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

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.''

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.

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.

Fusion rate success

Interbody fusion rate on CT based on Tan grades

Surgery duration

Surgery duration, min

Reoperations rate

Incidence of reoperations

Pelvic Incidence

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

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

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

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

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

Adverse Events

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

Full Information

NCT ID

NCT04594980

First Posted

October 10, 2020

Last Updated

October 24, 2023

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT04594980

Brief Title

Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 20, 2022 (Actual)

Primary Completion Date

February 10, 2024 (Anticipated)

Study Completion Date

February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar Spinal Stenosis, Intervertebral Disc Degeneration

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Minimally invasive TLIF

Arm Type

Other

Arm Description

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

Arm Title

Open TLIF

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

lumbar fusion

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in Oswestry Disability Index (ODI)

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Change from baseline in Oswestry Disability Index (ODI)

Description

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

Time Frame

Through 2 years

Title

Change from baseline in Numeric Pain Rating Score (NPRS)

Description

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

Time Frame

Through 2 years

Title

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

Description

Time Frame

Through 2 years

Title

Change from baseline in Douleur Neuropathique 4 (DN4)

Description

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

Time Frame

Through 2 years

Title

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

Description

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.''

Time Frame

Through 2 years

Title

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

Description

Time Frame

Through 2 years

Title

Cost-effectiveness

Description

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

Time Frame

14th day of hospital stay

Title

Fusion rate success

Description

Interbody fusion rate on CT based on Tan grades

Time Frame

12 months and 24 months post op

Title

Surgery duration

Description

Surgery duration, min

Time Frame

Day of surgery

Title

Reoperations rate

Description

Incidence of reoperations

Time Frame

Through 2 years

Title

Pelvic Incidence

Description

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

Time Frame

Through 2 years

Title

Change from baseline in Pelvic Tilt

Description

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

Time Frame

Through 2 years

Title

Change from baseline in Global Lordosis Angle

Description

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

Time Frame

Through 2 years

Title

Change from baseline in Segmental Lordosis

Description

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

Time Frame

Through 2 years

Title

Change from baseline in Sagittal Vertical Axis

Description

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

Time Frame

Through 2 years

Title

Adverse Events

Description

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

Time Frame

Through 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aleksandr Krutko, MD, PhD

Phone

+79139189603

ortho-ped@mail.ru

Facility Information:

Facility Name

Priorov National Medical Research Center of Traumatology and Orthopedics

City

Moscow

ZIP/Postal Code

127299

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aleksandr Krutko

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

33674366

Citation

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.

Results Reference

derived

Learn more about this trial

Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis

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