NCT03884283已完成不适用
A Post-market, Prospective, Multi-center, Nonrandomized Study to Assess Posterolateral Lumbar Fusions Using FIBERGRAFT BG Matrix
Prosidyan, Inc.18 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2019年2月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 18
- 主要终点
- Spinal fusion
研究概览
简要总结
This is a prospective, non-randomized (single arm), multi-center, post-market clinical study designed to evaluate FIBERGRAFT® BG Matrix mixed with autograft and bone marrow aspirate in up to 150 subjects with degenerative disc disease (DDD) with or without radiculopathy, or spinal stenosis and/or spondylolisthesis requiring a fusion. The patient population will include adult (skeletally mature) men and women undergoing 1 or 2 level fusion in the lumbar spine (L2-S1) who are deemed eligible for the study, characterized by inclusion and exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent Form
- •Is at least 18 years of age and skeletally mature.
- •Must have symptomatic spinal stenosis and/or spondylolisthesis or degenerative disc disease (DDD) at one or two adjacent levels from L2-S1, requiring a fusion.
- •Must have completed a minimum of three months of unsuccessful conservative, non-operative care.
- •DDD and spinal stenosis and/or spondylolisthesis must be confirmed by MRI or CT scans.
- •Must score at least 40 points on the Oswestry Disability Index.
- •Must score at least a 4 on a 10 cm Visual Analog Scale for back or leg pain.
- •Must be able to comply with the protocol's follow-up schedule.
- •Must understand and sign the IRB approved informed consent document.
排除标准
- •Symptomatic at more than two levels.
- •Previous fusion surgery at any lumbar level with or without instrumentation (prior discectomy, laminotomy, laminectomy or nucleolysis at the index level (> 6 months) is permitted).
- •Previous total disc replacement at any lumbar level.
- •Undergoing fusion for recurrent stenosis at the level to be treated.
- •Extraspinal cause of back and/or leg pain, or back and/or leg pain of unknown etiology.
- •Spondylolisthesis not able to be reduced to grade I.
- •Lumbar scoliosis greater than 11 degrees.
- •Osteoporosis*, osteopenia, osteomalacia, Paget's disease, or metabolic or systemic bone disorders that affect bone or wound healing.
- •Use of posterior instrumentation for stabilization is not possible.
- •Intra-operative soft tissue coverage is not possible.
- •Spinal tumors.
- •Active arachnoiditis.
- •Fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
- •Impaired calcium metabolism.
- •Active systemic infection or surgical site infection.
- •Osteomyelitis at the graft site.
- •Rheumatoid arthritis or other autoimmune disease.
- •Chronic steroid use (used steroids for one month within the last 6 months) or any medical condition that requires treatment with drugs known to interfere with bone healing.
- •Systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis.
- •Morbid obesity defined as body mass index (BMI) >40 or a weight more than 100 lbs over ideal body weight.
- •Smokers unless the subject agrees to quit at least 2 weeks prior to and for the duration of the study, confirmed by a carboxyhemoglobin test prior to surgery.
- •Psychosocial disorders that would preclude accurate evaluation or has a history of recent substance abuse.
- •Active malignancy except non-melanoma skin cancer; history of any invasive malignancy unless treated and in remission for at least five years.
- •Documented allergies to titanium.
- •Subjects with a history of anaphylaxis, history of multiple allergies, known allergies to bovine collagen, or who are being treated for desensitization to meat products because FIBERGRAFT® BG Matrix contains bovine collagen.
- •Pregnancy/able to become pregnant and not following a reliable contraceptive method, or interested in becoming pregnant in the next two years.
- •Participation in another investigational study within 30 days.
结局指标
主要结局
Spinal fusion
时间窗: 12 months
Spinal fusion will be determined via radiographic imaging at 12 months.
次要结局
未报告次要终点
研究者
研究点 (18)
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