3Spine Lumbar Fusion Real World Evidence Study

A Prospective Data Collection Study of Patients Treated With a Single-Level Lumbar Interbody Fusion Stabilized With Pedicle Screws

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Lumbar Spine Degeneration
• Intervention / Treatment: Device: Lumbar Interbody Fusion

Detailed Description

A prospective, multi-center (up to 20), non-blinded study of patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) stabilized with pedicle screws. Investigators will only select those patients who are planned for treatment with on-label use of FDA cleared TLIF/PLIF devices (cage and screw system).

An estimated 200 subjects with a potential sample size re-estimation at completion. The subjects will return for follow-up at 6-weeks, 3-months, 6-months, and then annually for 5-years post surgery.

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Todd Lanman MD, Inc.
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Steamboat Springs, Colorado, United States, 80487
      • Steamboat Orthopedics and Spine Institute (SOSI)
  • Florida
    • Deerfield Beach, Florida, United States, 33441
      • Spine & Orthopedic Center
    • Temple Terrace, Florida, United States, 33637
      • Florida Orthopaedic Institute
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Strenge Spine Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • The Spine Center of Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Spine Institute of Louisiana
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • East Syracuse, New York, United States, 13057
      • Upstate Orthopedics
    • New York, New York, United States, 10016
      • NYU Langone, Spine Research Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolina Neurosurgery and Spine Associates
    • Pinehurst, North Carolina, United States, 28374
      • Pinehurst Surgical Clinic
  • Ohio
    • Miamisburg, Ohio, United States, 45342
      • Vertrae Surgery Center
    • New Albany, Ohio, United States, 43054
      • OrthoNeuro
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73170
      • Oklahoma Center for Spine & Pain Solutions
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Center for Sports Medicine and Orthopaedics
  • Texas
    • San Antonio, Texas, United States, 78299
      • Ortho San Antonio
  • Utah
    • South Jordan, Utah, United States, 84088
      • The Disc Replacement Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

1. Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy;
2. Subject plans to undergo a one-level Open or Mini-Open TLIF or PLIF procedure (stabilized with pedicle screws) independent of this research protocol;
3. 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;

4. 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:

   1. Herniated nucleus pulposus;
   2. Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule;
   3. Facet joint degeneration/osteophyte formation;
   4. Spondylosis (defined by the presence of osteophytes);
   5. Disc degeneration and/or annular degeneration; and/or
   6. Lumbar stenosis defined by spinal cord or nerve root compression;
5. 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;
6. Preoperative Oswestry Disability Index score ≥ 40/100 at baseline;
7. 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
8. Signed informed consent.

Exclusion Criteria:

1. More than one vertebral level requiring treatment with instrumentation;
2. Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level;
3. Degenerative or lytic spondylolisthesis greater than Grade 1 (25% translation) associated with congenital (e.g. dysplastic) pars defects;
4. Rotatory scoliosis (>10 degrees) at the index level;
5. 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;
6. Subcaudal defect, disrupting the integrity of the pedicle that presents undue risk of device subsidence or migration due to compromised bone quality/density;
7. 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;
8. Disrupted anterior longitudinal ligament at the index level;
9. Overlying thoracolumbar kyphosis (greater than or equal to 15 degrees) within one level (includes target and adjacent level) of the level to be treated;
10. Back pain of unknown etiology without leg pain;

11. Severe spondylosis at the level to be treated as characterized by any of the following:

    1. Autofusion (solid arthrodesis) determined radiographically (CT);
    2. Totally collapsed disc, or;
    3. Vertebral body that cannot be mobilized;
12. Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, or vitamin E;
13. Unable to undergo a CT scan or other radiograph assessments;

14. 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;
15. 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);
16. Insulin-dependent diabetes mellitus;
17. Lactating, pregnant or interested in becoming pregnant in the next 3 years;
18. Active infection - systemic or local;
19. Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study;
20. Body Mass Index > 40;
21. Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolic disease;
22. Systemic disease including Lupus disease, Reiter's disease, Rheumatoid disease, AIDS, HIV, hepatitis or autoimmune disease that requires immunosuppressive therapy, including biologics, for systemic inflammation;
23. Spinal tumor at the index level or adjacent level that could compromise integrity of the implant (hemangiomas must be evaluated by the investigator and determined to not be pathologic, for example a biopsy may be required);
24. Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
25. Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis;
26. Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease;
27. Has a Waddell Signs of Inorganic Behavior score of 3 or greater;
28. In the opinion of the investigator, the subject has a behavioral, cognitive, social, or medical problem that may interfere with the assessment of the safety or effectiveness of the device;
29. Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 code; ;
30. Currently smoking or using tobacco products, including e-cigarette products (e.g., vaping) (Use within 30 days of surgery date is considered 'current');
31. Currently pursuing or in active spinal litigation for medical negligence, or trauma, or workers compensation;
32. Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results;
33. Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Score (VAS) - Worst Leg	Improvement in VAS - Worst leg of 20mm at 24 months compared to baseline. The VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain.	24 months compared to baseline
VAS - Back	Improvement in VAS - Back pain of 20mm at 24 months compared to baseline	24 months compared to baseline
ODI	Improvement in ODI of 15 points at 24 months compared to baseline	24 months compared to baseline
ODI	Mean change in ODI over time intervals	24 months compared to baseline
VAS	Mean change in leg VAS over time intervals	24 months compared to baseline
VAS	Mean change in back VAS over time intervals	24 months compared to baseline
Subsidence	Absence of radiographically confirmed subsidence >5mm	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS	Improvement in PROMIS scores	24 months compared to baseline
Demographics and intra-operative variables	The study will examine the patient population through descriptive statistics for demographics and intra-operative variables	24 months
Time to first SSI	Time to removal, revision, or supplemental fixation at the index level or adjacent level	24 months

Collaborators and Investigators

• Sponsor: 3Spine
• Collaborators: MCRA

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Actual): December 23, 2025
• Study Completion (Estimated): November 15, 2029

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Transforaminal lumbar interbody fusion; Posterior lumbar interbody fusion
• Other Study ID Numbers: 3Spine Lumbar Fusion Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Study being funded through private parties. IPD will not be shared in order to protect subject privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No