Clinical trial NCT04823858: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lumbar Spine Degeneration
Keywords: Posterior lumbar interbody fusion
Transforaminal lumbar interbody fusion
Lead sponsor: 3Spine
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2021-04-01
Enrollment: 176
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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 25), 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.

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 for all females age \<50 and males age \<55 to screen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXA scan is required. A DEXA scan is indicated for all females age ≥50 and all males age ≥55. 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 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.

Primary outcomes:
measure: Oswestry Disability Index (ODI) Score
timeFrame: 24 months compared to baseline
measure: Neurological Status
timeFrame: 24 months compared to baseline
measure: Secondary surgical intervention (SSI)
timeFrame: 24 months
measure: Serious device-related adverse events (SDAE)
timeFrame: 24 months
Secondary outcomes:
measure: Visual Analog Score (VAS) - Worst Leg
timeFrame: 24 months compared to baseline
measure: VAS - Back
timeFrame: 24 months compared to baseline
measure: ODI
timeFrame: 24 months compared to baseline
measure: ODI
timeFrame: 24 months compared to baseline
measure: VAS
timeFrame: 24 months compared to baseline
measure: VAS
timeFrame: 24 months compared to baseline
Other outcomes:
measure: PROMIS scores (Physical Function)
timeFrame: 24 months relative to the baseline
measure: PROMIS scores (Depression)
timeFrame: 24 months relative to the baseline
measure: PROMIS scores (Anxiety)
timeFrame: 24 months relative to the baseline
measure: PROMIS scores (Social roles/activities)
timeFrame: 24 months relative to the baseline
measure: Demographics
timeFrame: 24 months
measure: Demographics
timeFrame: 24 months
measure: Demographics
timeFrame: 24 months
measure: Intra-Operative Variables
timeFrame: 24 months
measure: Intra-Operative Variables
timeFrame: 24 months
measure: Time to first SSI
timeFrame: 24 months
measure: Radiographic fusion
timeFrame: 24 months
Locations:
city: Beverly Hills
country: United States
facility: Todd Lanman MD, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Steamboat Springs
country: United States
facility: Steamboat Orthopedics and Spine Institute (SOSI)
state: Colorado
city: Deerfield Beach
country: United States
facility: Spine & Orthopedic Center
state: Florida
city: Temple Terrace
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Paducah
country: United States
facility: Strenge Spine Institute
state: Kentucky
city: Baton Rouge
country: United States
facility: The Spine Center of Louisiana
state: Louisiana
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: East Syracuse
country: United States
facility: Upstate Orthopedics
state: New York
city: New York
country: United States
facility: NYU Langone, Spine Research Center
state: New York
city: Charlotte
country: United States
facility: Carolina Neurosurgery and Spine Associates
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Surgical Clinic
state: North Carolina
city: Miamisburg
country: United States
facility: Vertrae
state: Ohio
city: New Albany
country: United States
facility: OrthoNeuro
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma City Clinical Research Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Chattanooga
country: United States
facility: Center for Sports Medicine and Orthopaedics
state: Tennessee
city: San Antonio
country: United States
facility: Ortho San Antonio
state: Texas
city: South Jordan
country: United States
facility: The Disc Replacement Center
state: Utah
Study officials:
References: