3Spine Lumbar Fusion Real World Evidence Study

Running, not enrolling

Conditions studied: Lumbar Spine Degeneration

In brief

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).

Key facts

Study ID: NCT04823858
Run by: 3Spine
People needed: 176
Starts: 2021-05-25
Expected to finish: 2029-11-15
Last updated by the study team: 2026-06-30

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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;
Unable to undergo a CT scan or other radiograph assessments;
Osteopenia diagnosed by surgeon using a comprehensive assessment of all available information including the following:
DEXA bone density measured T-score ≤ -1:
Females age <50 and males age <55: The SCORE/MORES will be utilized to screen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXA scan is required.
Females age ≥50 and all males age ≥55: DEXA scan is required.
If indicated for DEXA, an existing scan is allowed if completed within 6 months of subject surgery;
Opportunistic quantitative CT (Hounsfield Units): Measurement is encouraged as supplemental information to determine potential for osteopenia;
Intra-operative evaluation of bone quality to assess if there is a significant risk for implant subsidence;
Has history of any endocrine or metabolic disorder known to affect osteogenesis (e.g.: Paget's disease, renal osteodystrophy, Ehler-Danlos syndrome, or osteogenesis imperfecta);
Insulin-dependent diabetes mellitus;

Where it is running

Todd Lanman MD, Inc. — Beverly Hills, California, United States
University of Colorado — Aurora, Colorado, United States
Steamboat Orthopedics and Spine Institute (SOSI) — Steamboat Springs, Colorado, United States
Spine & Orthopedic Center — Deerfield Beach, Florida, United States
Florida Orthopaedic Institute — Temple Terrace, Florida, United States
Strenge Spine Center — Paducah, Kentucky, United States
The Spine Center of Louisiana — Baton Rouge, Louisiana, United States
Spine Institute of Louisiana — Shreveport, Louisiana, United States
Mayo Clinic — Rochester, Minnesota, United States
Upstate Orthopedics — East Syracuse, New York, United States
NYU Langone, Spine Research Center — New York, New York, United States
Carolina Neurosurgery and Spine Associates — Charlotte, North Carolina, United States
Pinehurst Surgical Clinic — Pinehurst, North Carolina, United States
Vertrae Surgery Center — Miamisburg, Ohio, United States
OrthoNeuro — New Albany, Ohio, United States
Oklahoma Center for Spine & Pain Solutions — Oklahoma City, Oklahoma, United States
Thomas Jefferson University — Philadelphia, Pennsylvania, United States
Center for Sports Medicine and Orthopaedics — Chattanooga, Tennessee, United States
Ortho San Antonio — San Antonio, Texas, United States
The Disc Replacement Center — South Jordan, Utah, United States

Full record on ClinicalTrials.gov

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