CarboClear Pedicle Screw System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 14
- 主要终点
- Fusion: Evaluated Radiographically (by AP, Lateral and Flexion/Extension X-Rays) by Independent Radiographic Core Lab.
研究概览
简要总结
The purpose of this trial is to demonstrate the safety and effectiveness of the CarboClear Pedicle Screw System, for skeletally mature DDD patients undergoing one level spinal fusion in combination with interbody fusion device, and requiring immediate, rigid, posterior spinal stabilization of the lumbar and/or sacral spine.
详细描述
A prospective, multi-center, confirmatory, single arm, study. Results of the study will be compared to data from the literature.
The CarboClear Pedicle Screw System is designed for use with intervertebral body fusion device and with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, using PLIF or TLIF.
A total of 55 subjects will participate in the study, with up to 25 patients recruited at sites in Israel and at least 30 patients will be enrolled in US sites.
Follow-ups: Radiographic (AP, lateral and flexion/extension X-Rays) and clinical evaluations.
Follow-up sessions at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively, and then annually, until the last patient has completed 2-year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has degenerative disc disease (DDD) at one level, from L2 to S1 vertebrae, with up to Grade I spondylolisthesis.
- •DDD is defined as back pain and/or radicular leg pain with degeneration of the disc confirmed by patient history, radiographic studies, and physical examination, with one or more of the following factors (as measured radiographically, either by CT, MRI or plain film, myelography, discography, etc.):
- •osteophyte formation of facet joints or vertebral endplates;
- •decreased disc height, on average by > 2 mm;
- •scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule;
- •herniated nucleus pulposus;
- •facet joint degeneration/changes;
- •vacuum phenomenon.
- •Subject is candidate for single level intervertebral fusion, with or without posterolateral fusion, with implantation of intervertebral body fusion device and supplemental fixation.
- •Subject age is between 21 - 72 years, and subject is skeletally mature.
- •Pre-operative low back and/or leg/s pain (debilitating pain that causes a significant disturbance of the routine daily physical activities) ≥ 40 mm on a 100 mm Visual Analogue Scale (VAS).
- •Pre-operative Oswestry Disability Index (ODI) score ≥ 40 percentage-point, indicating at least moderate disability (interpreted as moderate/severe disability).
- •Low back and/or leg/s pain is unresponsive to prior non-surgical management for a minimum of six months. Non-operative treatment includes pain medication, physical therapy and/or injections.
- •Patient must understand and sign the informed consent.
- •Patient is willing and able to meet the proposed follow-up schedule including return to follow-up visits and complete necessary study paperwork.
- •Patient is willing and able to follow the postoperative management program.
排除标准
- •Previous fusion or fusion attempts, including anterior fusion or posterolateral fusion, at the index level.
- •Previous fusion or fusion attempts at the adjacent levels.
- •Prior decompression procedures that include removal of soft and bone tissue at the index or adjacent levels.
- •Patient is not skeletally mature.
- •Degenerative spondylolisthesis greater than Grade I.
- •Spinal instability at the index level with ≥ 3 mm translation and/or ≥ 5 degrees angulation. Determination of instability will be assessed using flexion/extension lateral view radiographs.
- •Isthmic spondylolisthesis.
- •Radiographically confirmed moderate or severe spinal stenosis with associated neurogenic claudication. Radiographically confirmed moderate/severe stenosis is defined as reduction of ˃50% of central and/or foraminal canal diameter compared to the adjacent uninvolved levels. Neurogenic claudication is leg, groin or buttock pain and/or numbness that worsens with walking or erect posture and is relieved with flexion of the spine.
- •Systemic infection or infection at the site of surgery.
- •Metabolic bone disease, such as osteopenia, osteoporosis, and osteomalacia. A screening Questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required, exclusion will be defined as measured T-score less than or equal to -2.5 (WHO definition).
- •History of Paget's disease or other bone pathologies, whether acquired or congenital, including renal osteodystrophy, untreated or uncontrolled hyperthyrodism, hypothyroidism, hyperparathyroidism, Ehrlers-Danlos-syndrome, osteogenesis imperfecta, achondroplasia, tuberculosis.
- •Personal and/or familial history NF2, and/or spinal tumor.
- •Ankylosing spondylitis.
- •Diffuse idiopathic skeletal hyperostosis (DISH) syndrome.
- •Active hepatitis (viral or serum) or HIV positive, renal failure, systemic lupus erythematosus, or any other significant medical conditions which would substantially increase the risk of surgery.
- •Immune deficiency disease.
- •Patient is receiving immunosuppressive or long-term steroid therapy.
- •Active malignancy or other significant medical comorbidities.
- •All concomitant diseases that can jeopardize the functioning and success of the patient.
- •Allergy to any component of the investigational device, including carbon fiber-reinforced polyetheretherketone (CFR-PEEK), titanium, and tantalum.
- •Pregnancy, or female subject interested in become pregnant during the duration of the study.
- •Current chemical dependency (e.g., drug and/or alcohol abuse, according to DSM-V definition), as well as those with a history of such abuse.
- •Uncontrolled depression, psychosis, or other symptoms of a mental disorder that, in the investigator's opinion, likely would make the subject unable to comply with the study procedures and could affect the study outcome.
- •Treatment with drugs that may interfere with bone metabolism, such as glucocorticosteroids, calcitonin, bisphosphonates, bone therapeutic doses of fluoride, bone therapeutic doses of vitamin D or vitamin D metabolites, and treatment by chemotherapy.
- •Morbid obesity (BMI ≥ 40).
- •Current smokers (including 3 months prior to surgery).
- •Scoliosis, Cobb angle greater than 11°.
- •Vertebral fractures.
- •Severe muscular, neural or vascular diseases that endanger the spinal column.
- •Missing bone structures, due to severely deformed anatomy or congenital anomalies, which make good anchorage of the implant impossible.
- •Current use of other investigational drug or device.
- •The patient is involved in a worker's compensation case or spine-related litigation.
- •The patient is a prisoner.
结局指标
主要结局
Fusion: Evaluated Radiographically (by AP, Lateral and Flexion/Extension X-Rays) by Independent Radiographic Core Lab.
时间窗: 24 months
Fusion was assessed at follow-up visits, starting at 6 months post operation. Fusion is defined as: 1. Angular motion ˂ 3º; AND 2. Translational motion ˂ 3 mm; AND 3. Presence of continuous bridging bone between the involved motion segment, i.e.: * Presence of interbody (between endplates) bridging bone and absence of radiolucency \> 50%; OR * Presence of right posterolateral bridging bone; OR * Presence of left posterolateral bridging bone.
Pain (Low Back and/or Leg/s): Assessed Based on Visual Analogue Scale (VAS) Patient Questionnaire
时间窗: 24 months
Pain was assessed using the Visual Analogue Scale (VAS) preoperatively and at follow-up visits. The scale ranges from 0 mm ("No Pain") to 100 mm ("Severe Pain"). Patients were instructed to draw a single line across the scale at the point that best described their level of pain. Pain improvement was evaluated at each location (i.e., low back, right leg, and left leg) and was defined as a reduction of at least 20 mm on a 100 mm VAS from baseline level at 24 months. Eligible patients experienced preoperative low back and/or leg pain (debilitating pain that significantly disrupted daily physical activities) with a VAS score of ≥40 mm.
Function: Assessed by Oswestry Disability Index (ODI) Patient Questionnaire
时间窗: 24 months
The Oswestry Disability Index (ODI) is a patient-reported questionnaire administered preoperatively and at follow-up visits. The ODI consists of ten questions focusing on pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. Each question has six possible responses. The response scale ranges from 0 to 5 points, with a lower score indicating better function and lower pain (0 points for full functionality with no or minimal pain; 5 points for inability to perform the function due to pain). The total ODI score is calculated by summing the individual question scores and dividing the total by the maximum possible score (50 if all questions are answered), yielding a percentage. ODI scores range from 0% to 100%, with lower percentages indicating reduced pain and disability. The functional outcome measure was defined as an improvement of at least 15 points from baseline at 24 months.
Safety: Neurological Deterioration, Device Related Serious Adverse Events, Additional Surgical Intervention at Index Level.
时间窗: Throughout the study until 24 months
1. Worsening in neurological status (motor, sensory, reflex, straight leg raising, and tenderness assessments) and no new permanent neurological deficits present for at least 2 successive visits at or beyond 6 months (out to 24 months); 2. Device-related serious adverse events (SAEs) through 24 months; 3. Subsequent surgical interventions at the index level through 24 months.
次要结局
- Subject's Overall Well-Being: Assessed by 12-Item Short Form Health Survey (SF-12) Patient Questionnaire(24 months)
- Patient Satisfaction: Assessed Based on VAS Patient Questionnaire.(24 months)
- Operation Time [Min](During operation (skin-to-skin))
- Blood Loss During Operation [ml](During operation (skin to skin))