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

NCT ID: NCT01024699

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spondylolisthesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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XLIF

This group will have the XLIF procedure done.

No interventions assigned to this group

MAS TLIF

This group will have the MAS TLIF procedure done.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NuVasive

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. Vincent-Jacksonville

Jacksonville, Florida, United States

Site Status

Celebration Florida Hospital

Kissimmee, Florida, United States

Site Status

St. Joseph's/Candler Health System

Savannah, Georgia, United States

Site Status

Northwest Orthopaedic Specialists, P.S.

Paducah, Kentucky, United States

Site Status

Orthopaedic Clinic-Riverside Campus, University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

The Methodist Hospital

Houston, Texas, United States

Site Status

Spine and Sports Institute

Richland, Washington, United States

Site Status

Northwest Orthopaedic Specialists, P.S.

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NUVA.X0901

Identifier Type: -

Identifier Source: org_study_id