Comparison of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2020-02-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. group - decompression, MIS TLIF + Screw Fixation
2. group - decompression, open fusion + Screw Fixation

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Minimally invasive fusion

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

Group Type EXPERIMENTAL

Decompression

Intervention Type PROCEDURE

Bilateral decompression

MIS TLIF

Intervention Type PROCEDURE

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

Screw Fixation

Intervention Type PROCEDURE

Transpedicular Screw Fixation

Open Fusion

Bilateral decompression, open fusion + screw fixation

Group Type ACTIVE_COMPARATOR

Decompression

Intervention Type PROCEDURE

Bilateral decompression

PLIF

Intervention Type PROCEDURE

Traditional open surgery

Screw Fixation

Intervention Type PROCEDURE

Transpedicular Screw Fixation

Interventions

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Decompression

Bilateral decompression

Intervention Type PROCEDURE

PLIF

Traditional open surgery

Intervention Type PROCEDURE

MIS TLIF

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

Intervention Type PROCEDURE

Screw Fixation

Transpedicular Screw Fixation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No