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Instr. vs. Non-instr. Posterolateral Spinal Fusion in Patients With Spinal Stenosis and Degenerative Listhesis

NCT04166981 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2022-03-31

No results posted yet for this study

Summary

The aim of this study is to determine, in patients with grade 1 degenerative spondylolisthesis with spinal stenosis, if decompression and lumbar spinal fusion with, or without supplementary pedicle screw fixation yields an improved patient reported outcome.

Conditions

  • Spinal Stenosis
  • Spondylolisthesis Degenerative
  • Spinal Fusion

Interventions

PROCEDURE

Instrumented posterolateral spine fusion.

Posterolateral fusion with autologous and allogenic bone graft with supplementary pedicle screw fixation.

PROCEDURE

Non-instrumented posterolateral spine fusion.

Posterolateral fusion with autologous and allogenic bone graft.

Sponsors & Collaborators

  • Spine Centre of Southern Denmark

    lead OTHER

Principal Investigators

  • Andreas K Andresen, MD · University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2021-12-01
Completion
2021-12-01

Countries

  • Denmark

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 NCT04166981 on ClinicalTrials.gov