SpondylolisthesisNCT01024699

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

An observational study of Spondylolisthesis, run by NuVasive at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Spondylolisthesis
How many people: 55 participants
Where: 9 sitesUnited States
Study dates: Nov 2009to Feb 2015
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Study population will consist of patients from participating site locations.

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Duke University Medical Center
Durham, North Carolina, 27710
The Methodist Hospital
Houston, Texas, 77030
St. Vincent-Jacksonville
Jacksonville, Florida, 32204
Celebration Florida Hospital
Kissimmee, Florida, 34747
Orthopaedic Clinic-Riverside Campus, University of Minnesota
Minneapolis, Minnesota, 55454
Northwest Orthopaedic Specialists, P.S.
Paducah, Kentucky, 42003
Spine and Sports Institute
Richland, Washington, 99352
St. Joseph's/Candler Health System
Savannah, Georgia, 31405
Northwest Orthopaedic Specialists, P.S.
Spokane, Washington, 99208

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Spondylolisthesis
Medical subject headings: Spondylolisthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01024699
Study group	Role	What they receive
XLIF		This group will have the XLIF procedure done.
MAS TLIF		This group will have the MAS TLIF procedure done.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

The average improvement in pain (VAS) at 24 months compared with baseline, for each procedure.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Feb 2015

First posted3 Dec 2009 (estimated)
Study startNov 2009
Primary completionFeb 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SpondylolisthesisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01024699
Sponsor's protocol ID: NUVA.X0901
Status last verified: Dec 2025
First submitted: 1 Dec 2009
Last updated: 24 Dec 2025
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
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All Spondylolisthesis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01024699
Acronym / sponsor ID: NUVA.X0901
Conditions: Spondylolisthesis
Study type: Observational
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: NuVasiveIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 3 Dec 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
XLIF	–	–This group will have the XLIF procedure done.
MAS TLIF	–	–This group will have the MAS TLIF procedure done.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Study population will consist of patients from participating site locations.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.

Related trials for Spondylolisthesis

Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Spondylolisthesis, run by NuVasive at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The average improvement in clinical function (ODI) at 24 months compared with baseline, for each procedure. (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01024699.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.