3Spine TLIF Real World Evidence Study

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 21 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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 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 cage 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, transcutaneous electrical nerve stimulation (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. Preoperative total leg pain and/or total back pain score > 40/100 on the Visual Analog Scale at baseline; 8. Surgical candidate for a posterior approach to the lumbar spine; 9. 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. 10. Signed informed consent.

Exclusion Criteria:

1. More than one vertebral level requiring treatment; 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); 4. Rotatory scoliosis at the level to be treated; 5. Congenital bony and/or spinal cord abnormalities at the level to be treated; 6. Subcaudal defect, disrupting the integrity of the pedicle; 7. Clinically compromised vertebral bodies at the involved 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 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 an MRI scan, CT scan or other radiograph assessments; 14. Osteopenia: All patients will complete SCORES/MORES to screen if a dual energy x-ray absorptiometry (DEXA) scan is indicated. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score ≤ -1. An existing DEXA is allowed if completed within 6 months of subject screening; 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; 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 Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) code; 30. Currently smoking or using tobacco products, including e-cigarette products (e.g., vaping); 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04823858
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

3Spine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lumbar Spine Degeneration, Spondylosis Lumbar, Spondylolisthesis, Grade 1, Lumbar Spinal Stenosis
Additional Details

A prospective, multi-center (up to 15), non-blinded study of patients who plan to undergo a single-level TLIF stabilized with pedicle screws. Investigators who perform instrumented TLIFs will be selected for participation prior to enrolling subjects into the study. Investigators will only select those patients who are planned for treatment with on-label use of FDA cleared TLIF devices (cage and screw system). At least 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.

Arms & Interventions

Arms

: 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 stabilized with pedicle screws and meet all of the eligibility criteria.

Interventions

Procedure: - Transforaminal Lumbar Interbody Fusion

The TLIF system includes a TLIF interbody cage and a pedicle screw system (4 screws with 2 rods). Any FDA cleared TLIF 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Todd Lanman MD, Inc., Beverly Hills, California

Status

Recruiting

Address

Todd Lanman MD, Inc.

Beverly Hills, California, 90210

Site Contact

Nicole Phillips

[email protected]

310-385-7766

University of Colorado, Aurora, Colorado

Status

Recruiting

Address

University of Colorado

Aurora, Colorado, 801111

Site Contact

Jiandong Hao

[email protected]

781-291-8040

Steamboat Springs, Colorado

Status

Recruiting

Address

Steamboat Orthopedics and Spine Institute (SOSI)

Steamboat Springs, Colorado, 80487

Site Contact

Abigial Wiedel

[email protected]

970-879-6663

Spine and Orthopedic Center, Deerfield Beach, Florida

Status

Recruiting

Address

Spine and Orthopedic Center

Deerfield Beach, Florida, 33441

Site Contact

Sara Saleh

[email protected]

515-554-7379

Paducah, Kentucky

Status

Recruiting

Address

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001

Site Contact

Rebekah Vinson

[email protected]

781-291-8040

Spine Institute of Louisiana, Shreveport, Louisiana

Status

Recruiting

Address

Spine Institute of Louisiana

Shreveport, Louisiana, 71101

Site Contact

Marcus Stone

[email protected]

781-291-8040

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Kelsey Klapperick

[email protected]

507-293-7392

Upstate Orthopedics, East Syracuse, New York

Status

Recruiting

Address

Upstate Orthopedics

East Syracuse, New York, 13057

Site Contact

Tina Craig

[email protected]

781-291-8040

NYU Langone, Spine Research Center, New York, New York

Status

Recruiting

Address

NYU Langone, Spine Research Center

New York, New York, 10016

Site Contact

Brooke O'Connell

[email protected]

646-794-8643

Charlotte, North Carolina

Status

Recruiting

Address

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 28204

Site Contact

Peggy Boltes

[email protected]

704-376-1605

Pinehurst Surgical Clinic, Pinehurst, North Carolina

Status

Recruiting

Address

Pinehurst Surgical Clinic

Pinehurst, North Carolina, 28374

Site Contact

Courtney Elliott

[email protected]

910-215-7648

OrthoNeuro, New Albany, Ohio

Status

Recruiting

Address

OrthoNeuro

New Albany, Ohio, 43054

Site Contact

Michelle Chao

[email protected]

614-839-3255

Chattanooga, Tennessee

Status

Recruiting

Address

Center for Sports Medicine and Orthopaedics

Chattanooga, Tennessee, 37404

Site Contact

Danette Newton

[email protected]

781-291-8040

Ortho San Antonio, San Antonio, Texas

Status

Recruiting

Address

Ortho San Antonio

San Antonio, Texas, 78299

Site Contact

Brouk Gebreab

[email protected]

781-291-8040