Status:
ACTIVE_NOT_RECRUITING
3Spine Lumbar Fusion Real World Evidence Study
Lead Sponsor:
3Spine
Collaborating Sponsors:
MCRA
Conditions:
Lumbar Spine Degeneration
Eligibility:
All Genders
21-80 years
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 in...
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) stabi...
Eligibility Criteria
Inclusion
- Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy;
- Subject plans to undergo a one-level Open or Mini-Open TLIF or PLIF procedure (stabilized with pedicle screws) independent of this research protocol;
- 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;
- 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:
- Herniated nucleus pulposus;
- Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule;
- Facet joint degeneration/osteophyte formation;
- Spondylosis (defined by the presence of osteophytes);
- Disc degeneration and/or annular degeneration; and/or
- Lumbar stenosis defined by spinal cord or nerve root compression;
- 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;
- Preoperative Oswestry Disability Index score \>/= 40/100 at baseline;
- 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
- Signed informed consent.
Exclusion
- More than one vertebral level requiring treatment;
- Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level;
- Degenerative or lytic spondylolisthesis greater than Grade 1 (\<25% translation);
- Rotatory scoliosis at the level to be treated;
- Congenital bony and/or spinal cord abnormalities at the level to be treated;
- Subcaudal defect, disrupting the integrity of the pedicle;
- 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;
- Disrupted anterior longitudinal ligament at the index level;
- Overlying thoracolumbar kyphosis (greater than or equal to 15 degrees) within one level (includes target and adjacent level) of the level to be treated;
- Back pain of unknown etiology without leg pain;
- Severe spondylosis at the level to be treated as characterized by any of the following:
- Autofusion (solid arthrodesis) determined radiographically (CT);
- Totally collapsed disc, or;
- Vertebral body that cannot be mobilized;
- Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, or vitamin E;
- Unable to undergo a CT scan or other radiograph assessments;
- 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;
- 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);
- Insulin-dependent diabetes mellitus;
- Lactating, pregnant or interested in becoming pregnant in the next 3 years;
- Active infection - systemic or local;
- 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;
- Body Mass Index \> 40;
- Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolic disease;
- 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;
- Spinal tumor;
- 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;
- 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;
- Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease;
- Has a Waddell Signs of Inorganic Behavior score of 3 or greater;
- 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;
- 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;
- Currently smoking or using tobacco products, including e-cigarette products (e.g., vaping); (Use within 30 days of surgery date is considered 'current');
- Currently pursuing or in active spinal litigation for medical negligence, or trauma, or workers compensation;
- Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results;
- 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.
Key Trial Info
Start Date :
May 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 15 2029
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT04823858
Start Date
May 25 2021
End Date
November 15 2029
Last Update
March 26 2025
Active Locations (20)
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1
Todd Lanman MD, Inc.
Beverly Hills, California, United States, 90210
2
University of Colorado
Aurora, Colorado, United States, 801111
3
Steamboat Orthopedics and Spine Institute (SOSI)
Steamboat Springs, Colorado, United States, 80487
4
Spine & Orthopedic Center
Deerfield Beach, Florida, United States, 33441