Clinical trial NCT01024699: XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis.
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondylolisthesis
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2009-12-03
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will consist of patients from participating site locations.

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.

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 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

Primary outcomes:
measure: The average improvement in clinical function (ODI) at 24 months compared with baseline, for each procedure.
timeFrame: 24 months
Secondary outcomes:
measure: The average improvement in pain (VAS) at 24 months compared with baseline, for each procedure.
timeFrame: 24 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: St. Vincent-Jacksonville
state: Florida
city: Kissimmee
country: United States
facility: Celebration Florida Hospital
state: Florida
city: Savannah
country: United States
facility: St. Joseph's/Candler Health System
state: Georgia
city: Paducah
country: United States
facility: Northwest Orthopaedic Specialists, P.S.
state: Kentucky
city: Minneapolis
country: United States
facility: Orthopaedic Clinic-Riverside Campus, University of Minnesota
state: Minnesota
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Richland
country: United States
facility: Spine and Sports Institute
state: Washington
city: Spokane
country: United States
facility: Northwest Orthopaedic Specialists, P.S.
state: Washington
Study officials:
References: