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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01024699

Enrollment

Registered

2009-12-03

Start date

2009-11-30

Completion date

2015-02-28

Last updated

2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondylolisthesis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The average improvement in clinical function (ODI) at 24 months compared with baseline, for each procedure.	24 months

Secondary

Measure	Time frame
The average improvement in pain (VAS) at 24 months compared with baseline, for each procedure.	24 months

Countries

United States

Outcome results