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

December 1, 2009
February 14, 2014
November 2009
February 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01024699 on ClinicalTrials.gov Archive Site
The average improvement in pain (VAS) at 24 months compared with baseline, for each procedure. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis.
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Study population will consist of patients from participating site locations.

Spondylolisthesis
Not Provided
  • XLIF
    This group will have the XLIF procedure done.
  • MAS TLIF
    This group will have the MAS TLIF procedure done.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
110
February 2015
February 2015   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01024699
NUVA.X0901
No
NuVasive
NuVasive
Not Provided
Not Provided
NuVasive
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP