NCT03748277

Brief Summary

The purpose of this study is to evaluate the clinical and radiological results of surgical treatment of one-level central stenosis of the lumbar spine using traditional open approach (PLIF) and a minimally invasive procedure (MIS TLIF). According to the hypothesis, we assume that unilateral approach of MIS TLIF allows for adequate bilateral decompression of one-level central stenosis of the lumbar spine. Using MIS TLIF it is possible to perform reliable fixation of a spine segment and the formation of a complete intervertebral bone fusion. The long-term clinical results of surgical treatment with minimally invasive technologies (MIS TLIF) and traditional open approach (PLIF) suspected to be comparable.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
Last Updated

May 14, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

November 15, 2018

Last Update Submit

May 12, 2020

Conditions

Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)

Keywords

intraoperative procedures

Outcome Measures

Primary Outcomes (1)

  • Oswestry Disability Index (ODI)

    Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 (the worst result, patient is not physically active). Maximum - 50 (the best result). Improvement of ODI post-operatively as compared to baseline

    Day of hospital discharge (10-15 day after surgery)

Secondary Outcomes (6)

  • Oswestry Disability Index (ODI)

    3, 6 and 12 months

  • VAS (back, leg)

    Day of hospital discharge (10-15 day after surgery), 3, 6 and 12 months

  • Surgery duration

    Day of surgery

  • Blood loss

    Day of surgery

  • MRI capacity spine canal

    Day of hospital discharge (10-15 day after surgery)

  • +1 more secondary outcomes

Study Arms (2)

Minimally invasive fusion

EXPERIMENTAL

Bilateral decompression using unilateral approach, MIS TLIF + screw fixation percutaneous

Procedure: DecompressionProcedure: MIS TLIFProcedure: Screw Fixation

Open Fusion

ACTIVE COMPARATOR

Bilateral decompression, open fusion + screw fixation

Procedure: DecompressionProcedure: PLIFProcedure: Screw Fixation

Interventions

DecompressionPROCEDURE

Bilateral decompression

Minimally invasive fusionOpen Fusion
PLIFPROCEDURE

Traditional open surgery

Open Fusion
MIS TLIFPROCEDURE

On the one side - Wiltse approach, on the other side - percutaneous

Minimally invasive fusion
Screw FixationPROCEDURE

Transpedicular Screw Fixation

Minimally invasive fusionOpen Fusion

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • syndrome of mono- or polyradicular compression of the nerve roots with / without a reflex pain syndromes, caused by stenosis of one lumbar spine segment;
  • intermittent claudication caused by stenosis of one lumbar spine segment;
  • one-level spine stenosis in combination with local segment instability or degenerative spondylolisthesis at the same spine segment, requiring fusion in only one lumbar segment

You may not qualify if:

  • bilateral foraminal lumbar spine stenosis;
  • lumbar spine stenosis more than one-level;
  • spondylolisthesis II degree and more;
  • sagittal imbalance;
  • fusion the same lumbar spine segment after surgery previously;
  • other diseases of the spine, including trauma, tumor and inflammatory diseases of the lumbar spine, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan

Novosibirsk, 630091, Russia

Location

MeSH Terms

Conditions

Disease

Interventions

Decompression

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPressureMechanical PhenomenaPhysical Phenomena

Study Officials

  • Aleksandr V Krutko, PhD, MD

    Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan, Neurosurgery Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 1. group - decompression, MIS TLIF + Screw Fixation 2. group - decompression, open fusion + Screw Fixation
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 20, 2018

Study Start

November 15, 2018

Primary Completion

February 15, 2019

Study Completion

February 15, 2020

Last Updated

May 14, 2020

Record last verified: 2020-02

Locations

RU(1)