A Prospective Analysis of the Efficacy of Allosync Expand and Autograft Bone Graft in Open Lumbar Spinal Fusion
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Lumbar fusion rate assessed via CT
研究概览
简要总结
The purpose of this study is to assess the radiographic and clinical outcomes of spinal fusion following use of Allosync Expand and autograft bone graft.
详细描述
This is a single site, prospective study with patients selected as study subjects from the Investigator's standard patient population who fulfill the Inclusion/Exclusion Criteria and agree to participate in the study. The study surgery is standard of care, with patients identified as requiring surgery prior to enrollment. The study surgery is lumbar posterior fixation with supplemental posterolateral fusion at from 1 to 3 levels. One side of the posterolateral fusion will be Allosync Expand (utilizing the BMA Angel kit to hydrate) and the other side to autograft bone (control).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 22years of age at the time of consent
- •Subject must have a documented diagnosis of spondylolisthesis up to Grade I. and have confirmed back and/or radicular pain with associated spinal stenosis as documented by conditions such as:
- •Instability as defined by >3mm translation or >5 degree angulation
- •Osteophyte formation of facet joints or vertebral endplates
- •Subject presents with one or more of the following:
- •Radiculopathy
- •Sensory deficit
- •Motor weakness
- •Reflex changes
- •Subject requires lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1).
- •The number of levels decompressed must equal the number of levels fused.
- •Subject must have been unresponsive to conservative care for at least 3 months prior to fusion surgery.
- •Subject must be willing and able to sign an informed consent document.
- •Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen.
排除标准
- •Subject has had prior lumbar spine fusion surgery at any level.
- •Subject has greater than grade 1 spondylolisthesis of the lumbar spine.
- •Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis
- •Subject has an active local or systemic infection.
- •Subject is a prisoner
- •Patient has any condition (including malignancy), that in the opinion of the Investigator, would prohibit the patient from complying with and/or completing the protocol
结局指标
主要结局
Lumbar fusion rate assessed via CT
时间窗: 12 months post surgery
Lumbar fusion rate assessed via CT at 12 months post surgery
次要结局
- Clinical outcome via PROMIS short form - Physical Evaluation(12 months post surgery)
- Clinical outcome via Overall Quality of Life (EQ-5D) EuroQol Research Foundation(12 months post surgery)
- Clinical outcome via neck visual analog scale (VAS)(12 months post surgery)