A Prospective, Post-Market, Multi-Center Study Evaluating ViBone® in Cervical and Lumbar Spine Fusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Elutia Inc.
- 入组人数
- 118
- 试验地点
- 4
- 主要终点
- Fusion Rates Per Level Using the Bridwell Interbody Grading Scale
研究概览
简要总结
Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.
详细描述
This study is a prospective, multi-center study to evaluate the clinical and radiographic outcomes of ViBone in patients undergoing ACDF or lumbar interbody fusion. Data will be gathered for subjects undergoing ACDF surgery and subjects undergoing lumbar fusion surgery using ViBone. Total enrollment is expected to be approximately 100 subjects. The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo 1-3 level ACDF or lumbar interbody fusion surgery using ViBone. Subjects will be followed for 12 months following surgery.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18-80 years of age
- •For cervical cases - ACDF surgery at 1, 2, or 3 contiguous levels between C2-C7
- •For lumbar cases - lumbar interbody fusion surgery at 1, 2, or 3 contiguous levels between L1-S1
- •Patient signed Consent Form with HIPAA Authorization
- •Appropriate candidate for surgery
- •Patient will adhere to the scheduled follow-up visits and requirements of the protocol including routine patient exams - pre-operative, operative, and at least two post- operative visits (6 and 12 months post-surgery). Pre-operative and post-operative visits include X-ray (required) and CT scan (if available).
排除标准
- •Long term use of medications that are known to inhibit fusion or bone metabolism or immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, DMARDs, etc.)
- •Treatment with radiotherapy
- •Acute or chronic systemic or localized spinal infections
- •Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical (for ACDF patients) or lumbar (for TLIF, PLIF, ALIF, or LLIF patients) spine
- •Previous pseudoarthrosis at any level of the cervical (for ACDF patients) or lumbar (for
- •TLIF, PLIF, ALIF, or LLIF patients) spine
- •Nursing mothers or women who are pregnant or plan to become pregnant during the course of the study
- •Current or recent history of malignancy or infectious disease. Patients with current or recent history of basal cell carcinoma are eligible.
- •Inability to provide informed consent
- •Rapid joint disease, bone absorption, osteomalacia, and/or diagnosed osteoporosis (bone density score of ≤-2.5).
- •Other medical or surgical conditions which would preclude the potential benefit of surgery, such as congenital abnormalities, immunosuppressive disease, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count.
- •Active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection.
结局指标
主要结局
Fusion Rates Per Level Using the Bridwell Interbody Grading Scale
时间窗: 12 months
Successful fusion rates for ViBone as defined by Grade I or II level of fusion on the Bridwell Interbody Grading Scale (below). The percentages below show at 12 months the amount of fusion per level for cervical and lumbar fusion procedures utilizing ViBone. Grade I: Fused with remodeling and trabeculae present. Grade II: Graft intact, not fully remodeled and incorporated, but no lucency present. Grade III: Graft intact, potential lucency present at top and bottom of graft. Grade IV: Fusion absent with collapse/resorption of graft.
次要结局
- Percent Change From Baseline in Oswestry Disability Index (ODI) at 12 Months(Baseline and 12 months)
- Percent Change From Baseline in Neck Disability Index (NDI) at 12 Months(Baseline and 12 months)
- Percent Change From Baseline in Visual Analog Scale (VAS) at 12 Months(Baseline and 12 months)