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Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

NCT04415814 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-09-25

No results posted yet for this study

Summary

Determining the treatment strategy for patients with degenerative diseases of the spine is extremely difficult, without an accurate understanding of the nature of stress distribution in the vertebral-motor segments of the spine, as well as biomechanical changes that are associated with degenerative diseases of the spine. In this clinical study, we want to compare the use of unilateral and bilateral transpedicular fixation for treating the patients with degenerative diseases of the lumbar spine.

Conditions

  • Fusion of Spine

Interventions

PROCEDURE

Unilateral Pedicle Screw Fixation

Pedicle screws are installed unilaterally on the one side of the vertebrae and fixed with rod

PROCEDURE

Bilateral Pedicle Screw Fixation

Pedicle screws are installed bilaterally on the both sides of the vertebrae and fixed with rods

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Alexey Lychagin, MD, PhD · IM Sechenov University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-06-30
Completion
2022-08-31

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 NCT04415814 on ClinicalTrials.gov