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

Completed

• Conditions: Spondylolisthesis

• Registration Number: NCT01024699
• Lead Sponsor: NuVasive

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-03
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (8)

St. Vincent-Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Celebration Florida Hospital; 🇺🇸 Kissimmee, Florida, United States

St. Joseph's/Candler Health System; 🇺🇸 Savannah, Georgia, United States

Northwest Orthopaedic Specialists, P.S.; 🇺🇸 Spokane, Washington, United States

Orthopaedic Clinic-Riverside Campus, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

The Methodist Hospital; 🇺🇸 Houston, Texas, United States

Spine and Sports Institute; 🇺🇸 Richland, Washington, United States