NCT03871400暂停不适用
Comparison of Early Fusion Using a NanoMetalene® Implant Versus Both PEEK and Allograft Implants in Anterior Cervical Discectomy and Fusion (ACDF) With OsteoStrand™ Demineralized Bone Fibers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 18
- 试验地点
- 22
- 主要终点
- Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
研究概览
简要总结
A prospective, multi-center, randomized, self-controlled, single-blinded, clinical study evaluating the NanoMetalene implant as compared to the PEEK and allograft implants in ACDF for the treatment of cervical degenerative disc disease (DDD).
详细描述
PEEK: Polyetheretherketone ACDF: Anterior cervical discectomy and fusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cervical degenerative disc disease
- •Requires primary spinal fusion from C3-C7
- •Minimum of 6 weeks of non-operative treatment
- •Signed informed consent form
排除标准
- •Uncontrolled type I or II diabetes mellitus
- •Morbid obesity
- •Documented history of alcohol or drug abuse
- •Fever or leukocytosis
- •Current systemic infection
- •Active malignancy and/or current chemotherapy
- •Known history of osteoporosis
- •Prior fusion or total disc replacement at the operative level or an adjacent level
- •Infection of the operative site
- •Use of implants from other systems
- •Pregnancy
- •Participation in another research study
结局指标
主要结局
Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
时间窗: 12 months
Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
次要结局
- Secondary CT Analysis: PEEK(12 months)
- Secondary CT Analysis: Allograft(12 months)
- Secondary X-Ray Analysis(24 months)
- Clinical Outcomes: NDI(24 months)
- Clinical Outcomes: VAS Arm(24 months)
- Clinical Outcomes: VAS Neck(24 months)
研究者
研究点 (22)
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