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Interbody vs Instrumented Posterolateral Fusion Following Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis

NCT01921530 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2018-08-20

No results posted yet for this study

Summary

Degenerative spondylolisthesis describes the slip of one spinal segment relative to the adjacent segment. It is usually associated with spinal stenosis (which limits one's ability to walk and stand) and is the most common indication for surgery in adults over age 65 years. A variety of surgical techniques are available; the most common are the Posterolateral Instrumented Fusion (PLF), and Interbody Fusion (IF) including Posterolateral Interbody Fusion (PLIF), and Transforaminal Interbody fusion (TLIF). IF uses a cage that is placed within the cleaned out disc space between the vertebral bodies being fused. Although this approach achieves a good fusion rate and deformity correction it is associated with a higher surgical cost and potential intra-operative complication rate. What is more, no consensus exists as to whether IF provides better patient rated functional outcome and quality of life. If the advantages of IF do not translate into superior patient rated outcomes, then the risk-benefit ratio would be tipped in favor of PLF. The purpose of this study is to determine if IF is equivalent to PLF for the treatment of degenerative spondylolisthesis. The investigators will conduct a prospective randomized control trial comparing these two procedures. Our primary outcome measure will be the Oswestry Disability Index, which evaluates spinal pain and function.

Conditions

  • Degenerative Spondylolisthesis
  • Spinal Stenosis

Interventions

PROCEDURE

Interbody Fusion

The interbody fusion (IF) procedure requires exposure and removal of the disc, curetting the end plates, inserting a cage filled with bone graft, as well as stabilization with rods and screws.

PROCEDURE

Posterolateral Fusion

In posterolateral fusion stabilization is achieved using pedicle screws joined by rods. The graft used to facilitate fusion is placed between decorticated transverse processes and can be an autograft of iliac bone or local bone, allograft, or a synthetic expander.

Sponsors & Collaborators

  • The London Spine Centre

    lead OTHER

Principal Investigators

  • Christopher S Bailey, MD · The London Spine Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2018-12-31
Completion
2019-12-31

Countries

  • Canada

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 NCT01921530 on ClinicalTrials.gov