A Prospective Data Collection Study of Patients Treated With a Single-Level Lumbar Interbody Fusion Stabilized With Pedicle Screws
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 176
- 试验地点
- 40
- 主要终点
- Serious device-related adverse events (SDAE)
研究概览
简要总结
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).
详细描述
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).
An estimated 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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, 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.
排除标准
- •More than one vertebral level requiring treatment with instrumentation;
- •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) associated with congenital (e.g. dysplastic) pars defects;
- •Rotatory scoliosis (>10 degrees) at the index level;
- •Congenital bony and/or spinal cord abnormalities at the index level to be treated such as conjoined nerve roots that would otherwise prevent placement of the device without generating nerve damage or skeletal malformations such as kyphotic vertebra that may be suited for a different course of treatment;
- •Subcaudal defect, disrupting the integrity of the pedicle that presents undue risk of device subsidence or migration due to compromised bone quality/density;
- •Clinically compromised vertebral bodies at the index 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 diagnosed by surgeon using a comprehensive assessment of all available information including the following:
- •DEXA bone density measured T-score ≤ -1:
- •Females age <50 and males age <55: 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.
- •Females age ≥50 and all males age ≥55: DEXA scan is required.
- •If indicated for DEXA, an existing scan is allowed if completed within 6 months of subject surgery;
- •Opportunistic quantitative CT (Hounsfield Units): Measurement is encouraged as supplemental information to determine potential for osteopenia;
- •Intra-operative evaluation of bone quality to assess if there is a significant risk for implant subsidence;
- •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 at the index level or adjacent level that could compromise integrity of the implant (hemangiomas must be evaluated by the investigator and determined to not be pathologic, for example a biopsy may be required);
- •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 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.
研究组 & 干预措施
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.
干预措施: Lumbar Interbody Fusion (Device)
结局指标
主要结局
Serious device-related adverse events (SDAE)
时间窗: 24 months
Absence of serious device-related adverse events at 24 months, as adjudicated by the CEC (SDAE) (SDAE are events whose relationship is determined to be possibly related, probably related, or definitely related)
Oswestry Disability Index (ODI) Score
时间窗: 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.
Secondary surgical intervention (SSI)
时间窗: 24 months
No subsequent surgical intervention including revision, re-operation, removal, or supplemental fixation at the index level
Neurological Status
时间窗: 24 months compared to baseline
Maintenance or improvement in neurological status at 24 months compared to baseline, as adjudicated by CEC. Neurological examination will consist of a motor and sensory examination at each in person study visit conducted per physician standard of care.
次要结局
- VAS(24 months compared to baseline)
- VAS - Back(24 months compared to baseline)
- ODI(24 months compared to baseline)
- Visual Analog Score (VAS) - Worst Leg(24 months compared to baseline)