Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis

Not Applicable

Active, not recruiting

• Conditions: Intervertebral Disc Degeneration; Lumbar Spinal Stenosis
• Interventions: Procedure: lumbar fusion

• Registration Number: NCT04594980
• Lead Sponsor: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-10
• Study First Submitted QC: 2020-10-17
• Study First Posted: 2020-10-20
• Study Start: 2022-01-20
• Primary Completion: 2024-02-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open TLIF	lumbar fusion	Patients will undergo a single level decompression and fusion using an open traditional technique. Followed posterior screw fixation is mandatory.
Minimally invasive TLIF	lumbar fusion	Patients will undergo a single level decompression and fusion using a minimally invasive technique. Followed posterior screw fixation is mandatory.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Oswestry Disability Index (ODI)	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 Outcome Measures

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

Trial Locations

Locations (1)

Priorov National Medical Research Center of Traumatology and Orthopedics; 🇷🇺 Moscow, Russian Federation