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OpenTrials
Completed

NCT Number: NCT01024699

XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis.

The purpose of this study is to determine differences in the XLIF and TLIF procedures with respect to perioperative variables in adult patients with low-grade symptomatic spondylolisthesis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Vincent-Jacksonville, Jacksonville, Florida, United States

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About this study

The study is a prospective multi-center randomized evaluation of clinical and radiographic outcomes of two commonly used lumbar interbody fusion procedures (XLIF and TLIF) in adult patients with low-grade symptomatic spondylolisthesis. The study seeks to identify differences between the procedures with respect to perioperative variables.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients who are at least 18 years of age;
  • Patients who present with symptomatic Grade I or II degenerative spondylolisthesis at 1 or 2 contiguous lumbar levels between L1 and L5 and are surgical candidates for interbody lumbar fusion surgery; symptoms should include radiculopathy and/or neurogenic claudication with or without back pain;
  • Patients who have been unresponsive to at least 6 months of conservative treatments or exhibit progressive neurological symptoms in the face of conservative treatment;
  • Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study.

Exclusion criteria

  • Patients with lumbar pathologies requiring treatment at more than 2 levels;
  • Patients who have had previous lumbar fusion surgery;
  • Patients with lytic spondylolisthesis or a defect of the pars interarticularis;
  • Patients with radiographic confirmation of Grade IV facet joint disease or degeneration;
  • Patients with non-contained or extruded herniated nucleus pulposus

Treatment and study plan

Primary outcomes

  1. The average improvement in clinical function (ODI) at 24 months compared with baseline, for each procedure.

    Time frame: 24 months

Secondary outcomes

  1. The average improvement in pain (VAS) at 24 months compared with baseline, for each procedure.

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

NuVasive

Industry

Registry information

Official study title

A Prospective Multi-Center Randomized Evaluation of the Clinical and Radiographic Outcomes of XLIF® Compared With MAS® TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2009
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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