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

Tracking Information

• First Submitted Date: March 24, 2021
• First Posted Date: April 1, 2021
• Last Update Posted Date: May 11, 2023
• Actual Study Start Date: May 25, 2021
• Estimated Primary Completion Date: August 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 6, 2022)

• 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.
• 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.
• 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.
• 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)

Original Primary Outcome Measures (submitted: March 29, 2021)

• 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.
• Absence of deterioration in 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.
• Absence of Secondary surgical intervention (SSI) [ Time Frame: 24 month ]
  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.
• Absence of serious device-related adverse events (SDAE) [ Time Frame: 24 month ]
  Subject success will be determined with the absence of any serious device-related adverse events (SDAE)

Current Secondary Outcome Measures (submitted: July 6, 2022)

• 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.
• VAS - Back [ Time Frame: 24 months compared to baseline ]
  Improvement in VAS - Back pain of 20mm at 24 months compared to baseline
• ODI [ Time Frame: 24 months compared to baseline ]
  Improvement in ODI of 15 points at 24 months compared to baseline
• ODI [ Time Frame: 24 months compared to baseline ]
  Mean change in ODI over time intervals
• VAS [ Time Frame: 24 months compared to baseline ]
  Mean change in leg VAS over time intervals
• VAS [ Time Frame: 24 months compared to baseline ]
  Mean change in back VAS over time intervals

Original Secondary Outcome Measures (submitted: March 29, 2021)

• Patient-Reported Outcomes Measurement Information System (PROMIS) score [ Time Frame: 24 months compared to baseline ]
  PROMIS Computer Adaptive Test is a self-reported questionnaire to measure components of the subject's health and wellbeing, such as physical functioning and psychosocial status. Outcomes measurements will examine improvement of the PROMIS score compared to baseline.
• Visual Analog Score (VAS) [ Time Frame: 24 months compared to baseline ]
  Improvement in the Visual Analog Score (VAS) worst leg and back pain of 20 points. 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.
• Back VAS change [ Time Frame: 24 month ]
  Mean change in back VAS over time intervals
• Leg VAS change [ Time Frame: 24 month ]
  Mean change in leg VAS over time intervals
• ODI change [ Time Frame: 24 month ]
  Mean change in ODI over time intervals
• Time to first SSI [ Time Frame: 24 month ]
  Time to first SSI including specific actions (removal, revision, replacement, supplemental fixation) will be examined throughout the study.
• Radiographic fusion [ Time Frame: 24 month ]
  Radiographic fusion as defined by the Image Review Charter and assessed by an independent core laboratory.

Current Other Pre-specified Outcome Measures (submitted: July 6, 2022)

• PROMIS scores (Physical Function) [ Time Frame: 24 months relative to the baseline ]
  Improvement in PROMIS scores (PROMIS Physical Function) compared to baseline
• PROMIS scores (Depression) [ Time Frame: 24 months relative to the baseline ]
  Improvement in PROMIS scores (PROMIS Depression) compared to baseline
• PROMIS scores (Anxiety) [ Time Frame: 24 months relative to the baseline ]
  Improvement in PROMIS score (PROMIS Anxiety) compared to baseline
• PROMIS scores (Social roles/activities) [ Time Frame: 24 months relative to the baseline ]
  Improvement in PROMIS score (PROMIS Social Roles/activities) compared to baseline
• Demographics [ Time Frame: 24 months ]
  The study will examine the patient population through descriptive statistics of the demographic variable - age
• Demographics [ Time Frame: 24 months ]
  The study will examine the patient population through descriptive statistics of the demographic variable - Body Mass Index (BMI)
• Demographics [ Time Frame: 24 months ]
  The study will examine the patient population through descriptive statistics of the demographic variable - gender
• Intra-Operative Variables [ Time Frame: 24 months ]
  The study will examine the patient population through descriptive statistics of the intra-operative variable - surgery time.
• Intra-Operative Variables [ Time Frame: 24 months ]
  The study will examine the patient population through descriptive statistics of the intra-operative variable - blood loss
• 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
• Radiographic fusion [ Time Frame: 24 months ]
  Radiographic fusion as defined by the Image Review Charter and assessed by an independent core laboratory.

Original Other Pre-specified Outcome Measures (submitted: March 29, 2021)

• PROMIS scores (Physical Function) [ Time Frame: 24 months relative to the baseline ]
  Improvement in PROMIS scores (PROMIS Physical Function) compared to baseline
• PROMIS scores (Depression) [ Time Frame: 24 months relative to the baseline ]
  Improvement in PROMIS scores (PROMIS Depression) compared to baseline
• PROMIS scores (Anxiety) [ Time Frame: 24 months relative to the baseline ]
  Improvement in PROMIS score (PROMIS Anxiety) compared to baseline
• PROMIS scores (Social roles/activities) [ Time Frame: 24 months relative to the baseline ]
  Improvement in PROMIS score (PROMIS Social Roles/activities) compared to baseline
• Stability with no subsidence [ Time Frame: 24 month ]
  Radiographic confirmation of stability with no subsidence >5mm as assessed by the independent core laboratory.
• Spondylolisthesis [ Time Frame: 24 month ]
  Radiographic (CT) confirmation of no more than 50% of increased spondylolisthesis as assessed by the independent core laboratory.
• Demographics [ Time Frame: 24 month ]
  The study will examine the patient population through descriptive statistics of the demographic variables.
• Intra-operative [ Time Frame: 24 month ]
  The study will examine the patient population through descriptive statistics of the intra-operative variables (surgery time, blood loss, and device types used)
• Steps walked/day measurement using Wearable device [ Time Frame: 24 month ]
  Comparison of wearable activity data of steps taken from baseline through post-operative follow-up. (optional cohort)
• Sleep data measurement using Wearable device [ Time Frame: 24 month ]
  Comparison of wearable sleep data taken from baseline through post-operative follow-up. (optional cohort)
• Caloric expenditure measurement using Wearable device [ Time Frame: 24 month ]
  Comparison of wearable caloric expenditure will be taken from baseline through post-operative follow-up. (optional cohort)
• EOS System Imaging [ Time Frame: 12 Month ]
  Baseline and 12 month EOS images will be collected for sites that have access to an EOS scanner. Evaluation will include an image comparison to baseline scan. This will be an optional sub-set of sites.

Descriptive Information

• Brief Title: 3Spine Lumbar Fusion Real World Evidence Study
• Official Title: A Prospective Data Collection Study of Patients Treated With a Single-Level Lumbar Interbody Fusion Stabilized With Pedicle Screws
• 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).

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 Type: Observational [Patient Registry]
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Biospecimen: Not Provided
• 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.
• Condition: Lumbar Spine Degeneration

Intervention

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.

Study Groups/Cohorts

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.

Intervention: Procedure: Lumbar Interbody Fusion

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 29, 2021): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 1, 2026
• Estimated Primary Completion Date: August 1, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04823858
• Other Study ID Numbers: 3Spine Lumbar Fusion Study
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: 3Spine
• Original Responsible Party: Same as current
• Current Study Sponsor: 3Spine
• Original Study Sponsor: Same as current
• Collaborators: MCRA
• Investigators: Not Provided
• PRS Account: 3Spine
• Verification Date: May 2023