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

Spondylolisthesis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024699
• Other study ID #: NUVA.X0901
• Status: Completed
• Phase: N/A
• First received: December 1, 2009
• Last updated: April 29, 2015
• Start date: November 2009
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spondylolisthesis

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	The Methodist Hospital	Houston	Texas
United States	St. Vincent-Jacksonville	Jacksonville	Florida
United States	Celebration Florida Hospital	Kissimmee	Florida
United States	Orthopaedic Clinic-Riverside Campus, University of Minnesota	Minneapolis	Minnesota
United States	Northwest Orthopaedic Specialists, P.S.	Paducah	Kentucky
United States	Spine and Sports Institute	Richland	Washington
United States	St. Joseph's/Candler Health System	Savannah	Georgia
United States	Northwest Orthopaedic Specialists, P.S.	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average improvement in clinical function (ODI) at 24 months compared with baseline, for each procedure.		24 months	Yes
Secondary	The average improvement in pain (VAS) at 24 months compared with baseline, for each procedure.		24 months	Yes