NCT04823858

Brief Summary

This study is designed to collect real world evidence (RWE) safety and efficacy data on patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) instrumented with pedicle screws, using the framework of a prospective clinical study (with defined enrollment criteria and pre-specified research follow-up timepoints).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
40mo left

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
May 2021Nov 2029

First Submitted

Initial submission to the registry

March 24, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 25, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2025

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2029

Expected
Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

4.6 years

First QC Date

March 24, 2021

Last Update Submit

June 26, 2026

Conditions

Lumbar Spine Degeneration

Keywords

Posterior lumbar interbody fusionTransforaminal lumbar interbody fusion

Outcome Measures

Primary Outcomes (4)

  • Oswestry Disability Index (ODI) Score

    Improvement of at least 15 points in ODI score (out of 100). The ODI is a self-reported questionnaire that contains ten sections concerning intensity of pain, lifting, personal care, walking, sitting, sexual function, standing, social life, sleeping and traveling.

    24 months compared to baseline

  • Neurological Status

    Maintenance or improvement in neurological status at 24 months compared to baseline, as adjudicated by CEC. Neurological examination will consist of a motor and sensory examination at each in person study visit conducted per physician standard of care.

    24 months compared to baseline

  • Secondary surgical intervention (SSI)

    No subsequent surgical intervention including revision, re-operation, removal, or supplemental fixation at the index level

    24 months

  • Serious device-related adverse events (SDAE)

    Absence of serious device-related adverse events at 24 months, as adjudicated by the CEC (SDAE) (SDAE are events whose relationship is determined to be possibly related, probably related, or definitely related)

    24 months

Secondary Outcomes (7)

  • Visual Analog Score (VAS) - Worst Leg

    24 months compared to baseline

  • VAS - Back

    24 months compared to baseline

  • ODI

    24 months compared to baseline

  • ODI

    24 months compared to baseline

  • VAS

    24 months compared to baseline

  • +2 more secondary outcomes

Other Outcomes (3)

  • PROMIS

    24 months compared to baseline

  • Demographics and intra-operative variables

    24 months

  • Time to first SSI

    24 months

Study Arms (1)

Examination Group

There will only be one arm of subjects in this study. The arm will include subjects who plan to undergo a single-level TLIF/PLIF stabilized with pedicle screws and meet all of the eligibility criteria.

Device: Lumbar Interbody Fusion

Interventions

Lumbar Interbody FusionDEVICE

The TLIF/PLIF system includes a TLIF/PLIF interbody cage and a pedicle screw system (4 screws with 2 rods). Any FDA cleared TLIF/PLIF interbody cage and pedicle screw system is acceptable for this study (with the exception of PEEK rods) as long as it is implanted per the package insert. No subjects implanted with an off-label use of a device are permitted for this study.

Examination Group

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects participating in this study will be recruited from the investigators' standard patient populations. Only patients who plan to undergo an Open or Mini-Open TLIF or PLIF procedure independent of this research protocol, are considered for study.

You may qualify if:

  • Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy;
  • Subject plans to undergo a one-level Open or Mini-Open TLIF or PLIF procedure (stabilized with pedicle screws) independent of this research protocol;
  • Subject is to be treated with on-label use of an FDA-cleared TLIF or PLIF cage(s) and pedicle screw system independent of this research protocol;
  • The subject has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar spine at a single level from L1/L2 to L5/S1 confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more than a Grade 1 (\<25% translation) spondylolisthesis. Symptomatic lumbar degeneration that may be associated with a co-morbid condition such as:
  • Herniated nucleus pulposus;
  • Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule;
  • Facet joint degeneration/osteophyte formation;
  • Spondylosis (defined by the presence of osteophytes);
  • Disc degeneration and/or annular degeneration; and/or
  • Lumbar stenosis defined by spinal cord or nerve root compression;
  • Exhausted conservative treatment (e.g. bed rest, physical therapy, medications, TENS, manipulation, and/or spinal injections) for at least 3 months or has a neurologic emergency;
  • Preoperative Oswestry Disability Index score ≥ 40/100 at baseline;
  • Psychosocially, mentally, and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms; and
  • Signed informed consent.

You may not qualify if:

  • More than one vertebral level requiring treatment with instrumentation;
  • Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level;
  • Degenerative or lytic spondylolisthesis greater than Grade 1 (25% translation) associated with congenital (e.g. dysplastic) pars defects;
  • Rotatory scoliosis (\>10 degrees) at the index level;
  • Congenital bony and/or spinal cord abnormalities at the index level to be treated such as conjoined nerve roots that would otherwise prevent placement of the device without generating nerve damage or skeletal malformations such as kyphotic vertebra that may be suited for a different course of treatment;
  • Subcaudal defect, disrupting the integrity of the pedicle that presents undue risk of device subsidence or migration due to compromised bone quality/density;
  • Clinically compromised vertebral bodies at the index level due to current or past trauma, e.g., by the radiographic appearance of the fracture callus, malunion or nonunion;
  • Disrupted anterior longitudinal ligament at the index level;
  • Overlying thoracolumbar kyphosis (greater than or equal to 15 degrees) within one level (includes target and adjacent level) of the level to be treated;
  • Back pain of unknown etiology without leg pain;
  • Severe spondylosis at the level to be treated as characterized by any of the following:
  • Autofusion (solid arthrodesis) determined radiographically (CT);
  • Totally collapsed disc, or;
  • Vertebral body that cannot be mobilized;
  • Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, or vitamin E;
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Todd Lanman MD, Inc.

Beverly Hills, California, 90210, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Steamboat Orthopedics and Spine Institute (SOSI)

Steamboat Springs, Colorado, 80487, United States

Location

Spine & Orthopedic Center

Deerfield Beach, Florida, 33441, United States

Location

Florida Orthopaedic Institute

Temple Terrace, Florida, 33637, United States

Location

Strenge Spine Center

Paducah, Kentucky, 42003, United States

Location

The Spine Center of Louisiana

Baton Rouge, Louisiana, 70809, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Upstate Orthopedics

East Syracuse, New York, 13057, United States

Location

NYU Langone, Spine Research Center

New York, New York, 10016, United States

Location

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 28204, United States

Location

Pinehurst Surgical Clinic

Pinehurst, North Carolina, 28374, United States

Location

Vertrae Surgery Center

Miamisburg, Ohio, 45342, United States

Location

OrthoNeuro

New Albany, Ohio, 43054, United States

Location

Oklahoma Center for Spine & Pain Solutions

Oklahoma City, Oklahoma, 73170, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Center for Sports Medicine and Orthopaedics

Chattanooga, Tennessee, 37404, United States

Location

Ortho San Antonio

San Antonio, Texas, 78299, United States

Location

The Disc Replacement Center

South Jordan, Utah, 84088, United States

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

April 1, 2021

Study Start

May 25, 2021

Primary Completion

December 23, 2025

Study Completion (Estimated)

November 15, 2029

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

This trial uses data date collected for a US FDA regulated PMA application. These data are proprietary and thus access is managed accordingly with dissemination considered after completion of FDA review. Beyond providing clinical evidence for a PMA, we plan to share findings through peer-reviewed publications \& scientific presentations. Prior to public release, data is reviewed for consistency with protocol, informed consent, participant confidentiality \& regulatory requirements. Data is verified for accuracy \& completeness, including demographics, operative details, functional assessments \& PROMs. After FDA review, de-identified data will be available to qualified investigators upon request contingent upon sponsor approval, available budget, a signed data use agreement, compliance with HIPAA \& terms of patient informed consent. The sponsor shall review requests for scientific merit, requestor qualifications, patient consent alignment \& regulatory obligations.

Locations

US(20)