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
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 18
- 试验地点
- 11
- 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
研究组 & 干预措施
NanoMetalene/PEEK
干预措施: Anterior cervical discectomy and fusion (Procedure)
NanoMetalene/Allograft
干预措施: Anterior cervical discectomy and fusion (Procedure)
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)