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Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis

NCT02564705 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 177

Last updated 2023-05-19

No results posted yet for this study

Summary

The aim of this study is to compare outcomes and cost-effectiveness of anterior versus posterior surgical treatment for lumbar Isthmic Spondylolisthesis. The primary objective is to compare treatment effectiveness in terms of functional outcomes as measured by Oswestry Disability Index (ODI) v2.1a and to compare safety outcomes measured by treatment-related adverse events. Secondary objectives are to compare treatments in terms of differences in pain, quality of life, health utilities, and need for re-operation. Finally, a cost-effectiveness analysis will be performed. This analysis will take the form of cost-effectiveness if there is a difference in treatment effects or cost-minimization if there is no difference in treatment efficacy.

Conditions

  • Isthmic Spondylolisthesis

Interventions

PROCEDURE

Anterior Lumbar Interbody Fusion (ALIF)

PROCEDURE

Posterior Fusion

* Posterolateral Fusion (PLF) * Posterior Lumbar Interbody Fusion (PLIF) * Transforaminal Lumbar Interbody Fusion (TLIF)

Sponsors & Collaborators

  • AOSpine North America Research Network

    lead NETWORK

Eligibility

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

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2023-05-05
Completion
2023-05-05

Countries

  • United States
  • 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 NCT02564705 on ClinicalTrials.gov