SPIRA™-A 3D Printed Titanium Anterior Lumbar Interbody Fusion Device and HCT/p Demineralized Bone Matrix Versus Medtronic Divergent™-L/Perimeter™ PEEK Anterior Lumbar Interbody Fusion Device and Recombinant Bone Morphogenic Protein-2
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Radiographic Fusion
研究概览
简要总结
A prospective, randomized, controlled clinical evaluation utilizing the SPIRA™ ALIF 3-D printed titanium interbody device with DBM vs a Medtronic PEEK ALIF interbody device with BMP
详细描述
This is a single blinded randomized 1:1, controlled, prospective clinical study to evaluate fusion status and patient reported outcomes in circumferential lumbar fusion between L2-S1 at a single level with posterior screw fixation (Camber Spine Orthros System) and anterior surgery consisting of one of the treatment groups: subjects treated with the SPIRA™-A Interbody Device and HCTP/p DBM or subjects treated with Medtronic Divergent-L or Perimeter™ PEEK ALIF Interbody Device and rhBMP-2 (6mg per level).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
subjects will be blinded prior to surgery. Following surgery, maintaining masking may not be feasible as subjects will have access to medical records and/or radiographs.
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •skeletally mature adults
- •completed 6 month non-operative or conservative therapy
- •signed informed consent
- •back pain with radicular symptoms as evidenced by leg pain
- •Degenerative Disc Disease involving a single level between L2 and S1
- •subject willing to participate in study and follow protocol
- •subject willing to comply with Post-op management program
排除标准
- •systemic infection such as AIDS, HIV or Active hepatitis
- •autoimmune disease
- •significant metabolic disease that might compromise bone growth
- •history of malignancy
- •previous surgery for primary tumor, trauma or infection
- •subject requires 2 or more levels of fusion
- •previous spinal instrumentation or previous interbody fusion at involved level
- •spondylolisthesis of grade greater than/equal to 2
结局指标
主要结局
Radiographic Fusion
时间窗: 24 months
AP/Lateral, Flexion, Extension and CT radiographs
次要结局
- Back and Leg VAS(up to and including 24 months)
- Oswestry Disability Index(up to and including 24 months)
- VR-12 Health Survey(up to and including 24 months)
- PROMIS score(up to and including 24 months)