Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01024699
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
NuVasive

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : November 2009
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
XLIF
This group will have the XLIF procedure done.
MAS TLIF
This group will have the MAS TLIF procedure done.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The average improvement in clinical function (ODI) at 24 months compared with baseline, for each procedure. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. The average improvement in pain (VAS) at 24 months compared with baseline, for each procedure. [ Time Frame: 24 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study population will consist of patients from participating site locations.
Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024699


Locations
Layout table for location information
United States, Florida
St. Vincent-Jacksonville
Jacksonville, Florida, United States, 32204
Celebration Florida Hospital
Kissimmee, Florida, United States, 34747
United States, Georgia
St. Joseph's/Candler Health System
Savannah, Georgia, United States, 31405
United States, Kentucky
Northwest Orthopaedic Specialists, P.S.
Paducah, Kentucky, United States, 42003
United States, Minnesota
Orthopaedic Clinic-Riverside Campus, University of Minnesota
Minneapolis, Minnesota, United States, 55454
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Washington
Spine and Sports Institute
Richland, Washington, United States, 99352
Northwest Orthopaedic Specialists, P.S.
Spokane, Washington, United States, 99208
Sponsors and Collaborators
NuVasive
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT01024699    
Other Study ID Numbers: NUVA.X0901
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylolisthesis
Spondylolysis
Spondylosis
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases