REFINE Study: A Prospective, Observational, Open-Label, Non-Randomized, Multi-Center Study Measuring Functional Outcomes In a Novel Interspinous Fusion Device In Subjects With Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 20
- 主要终点
- To evaluate the efficacy and safety of the Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material based on improvement in composite endpoints relative to baseline at 3 and 12 months 1. > 20mm pain reduction in VAS Back while standing
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of the use of Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material in fusion in patients with chronic low back pain that present with degenerative disc disease with concurrent neurogenic claudication.
详细描述
INTRODUCTION
This study will evaluate the effectiveness and safety of the use of Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material in single-level fusion in patients with chronic low back pain that present with degenerative disc disease (DDD) with concurrent neurogenic claudication.
Devices included in study are the Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material. The device is a bilateral locking plate system which attaches to the spinous processes of the posterior noncervical spine (T1-S1) from an interlaminar approach. The implants have superior and inferior spinous process articulations and a central bone graft chamber.
The Aurora Spine ZIP™ is used to treat DDD (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The studied indication is lumbar degenerative disease resulting in back pain with lower extremity symptoms and neurogenic claudication.
Degenerative disc disease is a common condition of the aging spine, and may contribute to a variety of painful symptoms, including radiculopathy, neurogenic claudication, and back pain. There are a number of mechanical sequelae that result from these degenerative processes of the intervertebral disc, which may manifest in the anterior, middle, and posterior columns of the spine. Symptoms of degenerative disc disease have traditionally been treated with a variety of conservative (pain medications, physical therapy, epidural steroid injections) and invasive (surgical decompression and/or fusion) options(1,2). Interspinous spacers (ISS) have been proven to be effective for neurogenic claudication with 5 year outcome data and robust clinical experience (3). More invasive treatment options for lumbar spinal stenosis include decompressive laminectomies and a variety of approaches to lumbar fusion.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects enrolled in this study must meet ALL of the following inclusion criteria:
- •Subject must provide written informed consent prior to any clinical study-related procedure.
- •Subject is at least 18 years or older at the time of enrollment, skeletal mature.
- •Subject has 1-2 symptomatic lumbar degenerative disease at adjacent level, T12-S1, with or without grade I spondylolisthesis (confirmed by history and radiographic studies).
- •MRI within 12 months prior to the procedure with at least mild to moderate spinal stenosis at the index treatment level
- •Subject has undergone at least 3 months of non-operative treatment.
- •Subject presents with ZCQ physical function ≥ 2.0 at baseline.
- •Subject reports relief from lumbar flexion and/or sitting.
- •Subject has baseline VAS of back and/or leg pain standing or walking ≥ 50mm.
排除标准
- •Subjects enrolled in this study must NOT meet any of the following exclusion criteria:
- •Subject is unable to provide written informed consent.
- •Subject has had previous lumbar spine surgery at the intended treatment level (e.g., laminectomy or fusion).
- •Subject has a grade II or greater spondylolisthesis on flexion and extension radiographs with 3mm instability.
- •Subject has confirmed or suspected osteoporosis or osteopenia.
- •Subject is enrolled, or intends to participate, in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug, or additional testing beyond standard of care procedures) which could confound the results of this trial as determined by the investigator.
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements.
- •Subject is pregnant or nursing.
结局指标
主要结局
To evaluate the efficacy and safety of the Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material based on improvement in composite endpoints relative to baseline at 3 and 12 months 1. > 20mm pain reduction in VAS Back while standing
时间窗: 12 months
The primary composite endpoint is individual patient success from baseline at 3- and 12-months of follow-up, which will be assessed as follows: 1. \> 20mm pain reduction in VAS Back while standing or walking 2. \> 20mm pain reduction in VAS Leg while standing or walking 3. Zurich Claudication Questionnaire improvement of 0.5 or greater in 2 or 3 domains) 4. ODI improvement of ≥ 10pts 5. No reoperations or revisions at the index level (s)
次要结局
- To characterize patient global impression of change (PGIC) relative to baseline at 3 and 12 months.(12 months)
- Imaging analysis(12 months)
- • To demonstrate real-world evidence of a significant improvement in the Pain Impact Score using ZIP™ as measured by the PROMIS-29 relative to baseline at 3 and 12 months.(12 months)
- • To identify patterns related to the influence of pharmacologic agents on response to therapy (and vice versa).(12 months)
- Complication Rate(12 months)