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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NuVasive
ClinicalTrials.gov Identifier:
NCT01024699
First received: December 1, 2009
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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
Spondylolisthesis

Study Type: Observational
Study Design: 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

Further study details as provided by NuVasive:

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

Secondary Outcome Measures:
  • The average improvement in pain (VAS) at 24 months compared with baseline, for each procedure. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: November 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
XLIF
This group will have the XLIF procedure done.
MAS TLIF
This group will have the MAS TLIF procedure done.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024699

Locations
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
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

No publications provided

Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT01024699     History of Changes
Other Study ID Numbers: NUVA.X0901
Study First Received: December 1, 2009
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Spondylolisthesis
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on October 29, 2014