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Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction

NCT03908203 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-09-11

No results posted yet for this study

Summary

This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia.

The current study is prospective pilot clinical study to demonstrate the possibility and effectiveness of performing modified technique of MIS TLIF, supplemented by segmental vertebrotomy, to correct segmental deformity of lumbar spine.

It is expected to enroll 10 patients aged 18-70 with segmental deformity of lumbar spine, caused by degenerative spondylolisthesis and/or degenerative stenosis.

Conditions

  • Intervertebral Disc Degeneration
  • Spinal Fusion

Interventions

PROCEDURE

Minimally invasive one-level lumbar deformity correction

The study treatment represents modified technique of MIS TLIF: one level screws fixation using Wiltse approach at one side, the other side - percutaneously, one level decompression, correction of segmental deformity by performing vertebrotomy and then intervertebral fusion.

Sponsors & Collaborators

  • DePuy International

    collaborator INDUSTRY

  • 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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-04-01
Completion
2022-04-01

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 NCT03908203 on ClinicalTrials.gov