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

NCT03748277 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2020-05-14

No results posted yet for this study

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.

Conditions

  • Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)

Interventions

PROCEDURE

Decompression

Bilateral decompression

PROCEDURE

PLIF

Traditional open surgery

PROCEDURE

MIS TLIF

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

PROCEDURE

Screw Fixation

Transpedicular Screw Fixation

Sponsors & Collaborators

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

    lead OTHER_GOV

Principal Investigators

  • Aleksandr V Krutko, PhD, MD · Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan, Neurosurgery Department

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2019-02-15
Completion
2020-02-15

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03748277 on ClinicalTrials.gov