3Spine Lumbar Fusion Real World Evidence Study

• ClinicalTrials.gov Identifier: NCT04823858
• Recruitment Status: Recruiting
• First Posted: April 1, 2021
• Last Update Posted: May 11, 2023
• Sponsor: 3Spine
• Collaborator: MCRA
• Information provided by (Responsible Party): 3Spine

Study Description

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).

Condition or disease	Intervention/treatment
Lumbar Spine Degeneration	Procedure: 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).

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.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 200 participants
• Observational Model: Other
• Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Official Title: A Prospective Data Collection Study of Patients Treated With a Single-Level Lumbar Interbody Fusion Stabilized With Pedicle Screws
• Actual Study Start Date: May 25, 2021
• Estimated Primary Completion Date: August 1, 2023
• Estimated Study Completion Date: August 1, 2026

Groups and Cohorts

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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures :

1. Oswestry Disability Index (ODI) Score [ Time Frame: 24 months compared to baseline ]
   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.
2. Neurological Status [ Time Frame: 24 months compared to baseline ]
   Absence of deterioration in neurological status compared to baseline examinations. Neurological examination will consist of a motor and sensory examination at each in person study visit conducted per physician standard of care.
3. Secondary surgical intervention (SSI) [ Time Frame: 24 months ]
   Subject success will be determined with the absence of a secondary surgical intervention including revision, re-operation, removal, or supplemental fixation at the index level.
4. Serious device-related adverse events (SDAE) [ Time Frame: 24 months ]
   Subject success will be determined with the absence of any serious device-related adverse events (SDAE)

Secondary Outcome Measures :

1. Visual Analog Score (VAS) - Worst Leg [ Time Frame: 24 months compared to baseline ]
   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.
2. VAS - Back [ Time Frame: 24 months compared to baseline ]
   Improvement in VAS - Back pain of 20mm at 24 months compared to baseline
3. ODI [ Time Frame: 24 months compared to baseline ]
   Improvement in ODI of 15 points at 24 months compared to baseline
4. ODI [ Time Frame: 24 months compared to baseline ]
   Mean change in ODI over time intervals
5. VAS [ Time Frame: 24 months compared to baseline ]
   Mean change in leg VAS over time intervals
6. VAS [ Time Frame: 24 months compared to baseline ]
   Mean change in back VAS over time intervals

Other Outcome Measures:

1. PROMIS scores (Physical Function) [ Time Frame: 24 months relative to the baseline ]
   Improvement in PROMIS scores (PROMIS Physical Function) compared to baseline
2. PROMIS scores (Depression) [ Time Frame: 24 months relative to the baseline ]
   Improvement in PROMIS scores (PROMIS Depression) compared to baseline
3. PROMIS scores (Anxiety) [ Time Frame: 24 months relative to the baseline ]
   Improvement in PROMIS score (PROMIS Anxiety) compared to baseline
4. PROMIS scores (Social roles/activities) [ Time Frame: 24 months relative to the baseline ]
   Improvement in PROMIS score (PROMIS Social Roles/activities) compared to baseline
5. Demographics [ Time Frame: 24 months ]
   The study will examine the patient population through descriptive statistics of the demographic variable - age
6. Demographics [ Time Frame: 24 months ]
   The study will examine the patient population through descriptive statistics of the demographic variable - Body Mass Index (BMI)
7. Demographics [ Time Frame: 24 months ]
   The study will examine the patient population through descriptive statistics of the demographic variable - gender
8. Intra-Operative Variables [ Time Frame: 24 months ]
   The study will examine the patient population through descriptive statistics of the intra-operative variable - surgery time.
9. Intra-Operative Variables [ Time Frame: 24 months ]
   The study will examine the patient population through descriptive statistics of the intra-operative variable - blood loss
10. Time to first SSI [ Time Frame: 24 months ]
    Time to first SSI including specific actions (removal, revision, replacement, supplemental fixation) at the index or adjacent level
11. Radiographic fusion [ Time Frame: 24 months ]
    Radiographic fusion as defined by the Image Review Charter and assessed by an independent core laboratory.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

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 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, 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. 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;
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 (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: 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. 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); (Use within 30 days of screening 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.

Contacts and Locations

Contacts

Contact: Kevin McGinnis; 781-291-8040; kevin.mcginnis@3spine.com

Locations

United States, California

Todd Lanman MD, Inc.; Active, not recruiting

Beverly Hills, California, United States, 90210

United States, Colorado

University of Colorado; Recruiting

Aurora, Colorado, United States, 801111

Contact: Jiandong Hao jiandong.hao@cuanschutz.edu

Contact: Victoria Li victoria.2.li@ucdenver.edu

Principal Investigator: Vikas Patel, MD

Sub-Investigator: CJ Kleck, MD

Sub-Investigator: David Ou-Yang, MD

Sub-Investigator: Nolan Wessell, MD

Steamboat Orthopedics and Spine Institute (SOSI); Active, not recruiting

Steamboat Springs, Colorado, United States, 80487

United States, Florida

Spine & Orthopedic Center; Recruiting

Deerfield Beach, Florida, United States, 33441

Contact: Filiz Gokce, MD, CCRP fgokce51@gmail.com

Principal Investigator: Ashish Sahai, MD

Florida Orthopaedic Institute; Recruiting

Temple Terrace, Florida, United States, 33637

Contact: Debbi Warren dwarren@foreonline.org

Principal Investigator: John Small, MD

Sub-Investigator: Brooks Osburn, MD

Sub-Investigator: Adil Samad, MD

Sub-Investigator: Steven Tresser, MD

United States, Kentucky

Orthopaedic Institute of Western Kentucky; Active, not recruiting

Paducah, Kentucky, United States, 42001

United States, Louisiana

Spine Institute of Louisiana; Active, not recruiting

Shreveport, Louisiana, United States, 71101

United States, Minnesota

Mayo Clinic; Active, not recruiting

Rochester, Minnesota, United States, 55905

United States, New York

Upstate Orthopedics; Active, not recruiting

East Syracuse, New York, United States, 13057

NYU Langone, Spine Research Center; Recruiting

New York, New York, United States, 10016

Contact: Ivanka Bhambhani Ivanka.Bhambhani@nyulangone.org

Principal Investigator: Jeffrey Goldstein, MD

Sub-Investigator: Jason Gallina, MD

Sub-Investigator: Charla Fischer, MD

Sub-Investigator: Yong Kim, MD

Sub-Investigator: Anthony Petrizzo, MD

Sub-Investigator: Themistocles Proptopsaltis, MD

Sub-Investigator: Jeffrey Spivak, MD

Sub-Investigator: Michael Smith, MD

United States, North Carolina

Carolina Neurosurgery and Spine Associates; Recruiting

Charlotte, North Carolina, United States, 28204

Contact: Ginger Barr Ginger.Barr@CNSA.com

Contact: David Cowan david.cowan@cnsa.com

Sub-Investigator: Domagoj Coric, MD

Sub-Investigator: Martin Henegar, MD

Sub-Investigator: Byron Branch, MD

Sub-Investigator: Paul Kim, MD

Sub-Investigator: Mark Smith, MD

Principal Investigator: John Parish, MD

Sub-Investigator: Matthew McGirt, MD

Sub-Investigator: Michael Bohl, MD

Pinehurst Surgical Clinic; Active, not recruiting

Pinehurst, North Carolina, United States, 28374

United States, Ohio

OrthoNeuro; Recruiting

New Albany, Ohio, United States, 43054

Contact: Missy Showe 614-839-3255 mshowe@theorthopedicfoundation.com

Principal Investigator: Ying Chen, DO

Sub-Investigator: David Kim, MD

Sub-Investigator: Larry Todd, DO

United States, Oklahoma

Oklahoma City Clinical Research Center; Recruiting

Oklahoma City, Oklahoma, United States, 73170

Contact: Celia Williams cwilliams@okspinecenter.com

Principal Investigator: Cheng-Lun Soo, MD

United States, Pennsylvania

Thomas Jefferson University; Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contact: Sara Thalheimer Sara.Thalheimer@jefferson.edu

Principal Investigator: Ahilan Sivaganesan, MD

Sub-Investigator: Joshua Heller, MD

Sub-Investigator: James Harrop, MD

Sub-Investigator: Jack Jallo, MD

Sub-Investigator: Srinivas Prasad, MD

United States, Tennessee

Center for Sports Medicine and Orthopaedics; Active, not recruiting

Chattanooga, Tennessee, United States, 37404

United States, Texas

Ortho San Antonio; Active, not recruiting

San Antonio, Texas, United States, 78299

United States, Utah

The Disc Replacement Center; Active, not recruiting

West Jordan, Utah, United States, 84088

Sponsors and Collaborators

3Spine

MCRA

More Information

• Responsible Party: 3Spine
• ClinicalTrials.gov Identifier: NCT04823858
• Other Study ID Numbers: 3Spine Lumbar Fusion Study
• First Posted: April 1, 2021
• Last Update Posted: May 11, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by 3Spine:

Posterior lumbar interbody fusion; Transforaminal lumbar interbody fusion