Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis

Lumbar Spinal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04594980
• Other study ID #: NS02-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2024
• Source: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: February 1, 2025
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Constriction, Pathologic
• Intervertebral Disc Degeneration
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• lumbar fusion
Transforaminal Lumbar Interbody Fusion will be performed using minimally invasive approach or traditional open technique.

Locations

Country	Name	City	State
Russian Federation	Priorov National Medical Research Center of Traumatology and Orthopedics	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
N.N. Priorov National Medical Research Center of Traumatology and Orthopedics

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Fusion rate success	Interbody fusion rate on CT based on Tan grades	12 months and 24 months post op
Secondary	Surgery duration	Surgery duration, min	Day of surgery
Secondary	Reoperations rate	Incidence of reoperations	Through 2 years
Secondary	Pelvic Incidence	To observe the sagittal balance parameter - Pelvic Incidence - by sagittal scans of spine by X-Ray, in degrees	Through 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse Events	Document Adverse Events (incl. adverse events related to device) occurrence throughout the study	Through 2 years