Clinical trial NCT04594980: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lumbar Spinal Stenosis
Intervertebral Disc Degeneration
Lead sponsor: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 96
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline in Oswestry Disability Index (ODI)
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline in Oswestry Disability Index (ODI)
timeFrame: Through 2 years
measure: Change from baseline in Numeric Pain Rating Score (NPRS)
timeFrame: Through 2 years
measure: Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D).
timeFrame: Through 2 years
measure: Change from baseline in Douleur Neuropathique 4 (DN4)
timeFrame: Through 2 years
measure: Change from baseline in The Health Transition Item from SF-36 (HTI Item)
timeFrame: Through 2 years
measure: Change from baseline in Clinical Global Impression Of Change (CGIC) scale
timeFrame: Through 2 years
measure: Cost-effectiveness
timeFrame: 14th day of hospital stay
measure: Fusion rate success
timeFrame: 12 months and 24 months post op
measure: Surgery duration
timeFrame: Day of surgery
measure: Reoperations rate
timeFrame: Through 2 years
measure: Pelvic Incidence
timeFrame: Through 2 years
measure: Change from baseline in Pelvic Tilt
timeFrame: Through 2 years
measure: Change from baseline in Global Lordosis Angle
timeFrame: Through 2 years
measure: Change from baseline in Segmental Lordosis
timeFrame: Through 2 years
measure: Change from baseline in Sagittal Vertical Axis
timeFrame: Through 2 years
measure: Adverse Events
timeFrame: Through 2 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Priorov National Medical Research Center of Traumatology and Orthopedics
Study officials:
References:
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.