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

NCT01024699 | Completed

• 1 other identifier: NUVA.X0901
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 9

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.

Conditions

Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

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

  24 months

Secondary Outcomes (1)

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

  24 months

Study Arms (2)

XLIF

This group will have the XLIF procedure done.

MAS TLIF

This group will have the MAS TLIF procedure done.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population will consist of patients from participating site locations.

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• NuVasive: lead

Study Sites (9)

St. Vincent-Jacksonville

Jacksonville, Florida, 32204, United States

Location

Celebration Florida Hospital

Kissimmee, Florida, 34747, United States

Location

St. Joseph's/Candler Health System

Savannah, Georgia, 31405, United States

Location

Northwest Orthopaedic Specialists, P.S.

Paducah, Kentucky, 42003, United States

Location

Orthopaedic Clinic-Riverside Campus, University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Spine and Sports Institute

Richland, Washington, 99352, United States

Location

Northwest Orthopaedic Specialists, P.S.

Spokane, Washington, 99208, United States

Location

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 3, 2009
• Study Start: November 1, 2009
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (9)