Spineology Clinical Outcomes Trial: An Investigation Device Exempt (IDE) Performance Goal Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 20
- 主要终点
- Overall Success
研究概览
简要总结
This study evaluated the safety and effectiveness of the Spineology Interbody Fusion System (SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic single-level lumbar degenerative disc disease.
详细描述
This regulated prospective, multi-center, Institutional Review Board (IRB) approved single-arm performance goal clinical investigation was conducted at 10 centers with 102 subjects being enrolled and treated.
Subjects were actively evaluated from pre-op to 24-months postoperative. Based on enrollment duration, some subjects were remotely assessed through self-administered surveys at 36- and/or 48-months.
The primary endpoint, assessed at 24-months postoperative, is a composite score that includes pain, function, fusion and safety assessments.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature;
- •Confirmed symptomatic single-level lumbar degenerative disc disease (DDD) between L2 and S1;
- •Minimum low back Visual Analog Scale (VAS) pain score of 40mm;
- •Minimum Oswestry Disability Index (ODI) score of 40;
- •Received at least 6-months of conservative care; and
- •Willing and able to comply with protocol evaluations and provide informed consent.
排除标准
- •Previous fusion or total disc replacement at the index level;
- •Greater than Grade I spondylolisthesis;
- •Has symptomatic multi-level lumbar DDD;
- •Active systemic infection or infection at the local surgical site;
- •Active or suspected malignancy;
- •Body Mass Index of greater than or equal to 40;
- •Significant metabolic bone disease;
- •Taking medication known to interfere with bone healing;
- •Has a current substance abuse disorder;
- •Has a somatoform, dissociative, eating or psychotic disorder;
- •Waddell Signs of inorganic behavior;
- •Current tobacco user;
- •Is a prisoner;
- •If female, pregnant or contemplating pregnancy during follow-up period; or
- •Enrolled in a concurrent clinical investigation that may confound the findings of the current investigation
结局指标
主要结局
Overall Success
时间窗: 24 months
The primary endpoint of this trial is the rate of Patient Success at 24-months defined as a composite endpoint that includes: 1. Pain -- Clinically meaningful reduction in low back pain Visual Analog Scale (VAS) score at 24-months post-operative. A clinically meaningful reduction is defined as a difference of at least 20 mm compared to pre-op (pre-op score minus post-op score). 2. Function -- Clinically meaningful improvement in function at 24-months post-operative. A clinically meaningful improvement is defined as a reduction of at least 15 points compared to baseline (pre-op Oswestry Disability Index (ODI) score minus the post-op ODI score). 3. Fusion -- Defined as bridging bone demonstrated on computed tomography (CT) scan 4. Safety -- No device-related serious adverse events (SAEs) from intra-op through the 24-month timepoint. For the study to be a success, 68% of subjects need to meet the above success criteria.
次要结局
未报告次要终点