NCT02814825已完成不适用
A Multi-Center, Prospective, Single-Arm Study of Patients Undergoing a Two or Three Level ACDF Using ViviGen Cellular Bone Matrix in Conjunction With Cervical Allograft Spacers and DePuy Synthes Spine Anterior Cervical Plate Systems
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- DePuy Spine
- 入组人数
- 100
- 主要终点
- Fusion
研究概览
简要总结
The purpose of this post-market study is to collect data on ViviGen and how its use affects fusion rates in the cervical spine when used as additional grafting material to fill the cervical spacer. The patient population of interest is patients who have already elected to undergo a 2-3 level ACDF surgical procedure using ViviGen, per standard of care.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates who satisfy ALL of the following inclusion criteria and consent to participate in the study may be considered eligible for enrollment:
- •Diagnosed by the investigator with at least one (1) of the following:
- •Symptomatic cervical spondylosis;
- •Degenerative disc disease (DDD), defined as discogenic pain with degeneration of the disc confirmed by history and imaging studies;
- •Herniated nucleus pulposus (HNP)
- •Subjects who are candidates and have already elected to undergo contiguous two or three-level ACDF surgery between C2-C7 of the cervical spine
- •Skeletally mature adults between 21 and 75 years of age
- •Subjects, who, in the opinion of the Investigator, are able to understand the purpose of the study and are willing to return for all the required post-operative standard of care follow-up visits and have their data collected.
排除标准
- •Candidates who meet ANY of the following exclusion criteria are not considered eligible for study participation:
- •Posterior instrumentation necessary at same levels being treated
- •Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine
- •Instability associated with cervical spine trauma
- •Acute or chronic systemic or localized spinal infections
- •Previous deep anterior cervical surgeries such as thyroid, carotid, or high thoracic surgery (T5 and above)
- •History of previous cervical fusion surgery at greater than one level
- •Previous pseudoarthrosis at any level of the cervical spine
- •Nursing mothers or women who are pregnant or plan to become pregnant during the time of the study
- •Severe osteoporosis (per the Investigator's diagnosis or per a T-score greater than or equal to 2.5 SD below the mean for a young, healthy adult) that may prevent adequate fixation of screws and thus preclude the use of a cervical plate system
- •Subjects who have a known or suspected allergy to any of the following antibiotics and/or reagents: Gentamicin Sulfate, Meropenem, Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin (HSA)
- •Immune compromised subjects
- •Pre-existing neurological abnormalities other than deficits produced by the spinal fusion (e.g. MS, Parkinson's, CVA, diabetic neuropathy, peripheral neuropathy)
- •Conditions that could preclude the possibility of fusion in the Investigator's opinion (e.g. cancer, kidney dialysis, smoking, uncontrolled diabetes, osteopenia)
- •History of pre-operative dysphagia
- •Symptomatic shoulder pathologies under active treatment
- •Known sensitivity to device materials
- •Subjects who, in the opinion of the Investigator, have any other existing condition that would compromise their participation and follow-up in this clinical study
- •Intraoperative exclusion criteria:
- •Intraoperative decision by the surgeon to use implants not compatible or cleared for use with ViviGen
- •Intraoperative decision by the surgeon to use other bone grafts substitutes such as DBM or rhBMP
研究组 & 干预措施
ViviGen
Patients undergoing a two or three level ACDF using ViviGen Cellular Bone Matrix in conjunction with cervical allograft spacers and DePuy Synthes anterior cervical plate systems.
干预措施: ViviGen (Other)
结局指标
主要结局
Fusion
时间窗: 12 Months
An independent radiologist will review films to determine fusion
次要结局
- Time to Fusion(12 Months)
- NDI (Neck Disability Index)(12 Months)
- OR (Operating Room) Time(0 Days)
- SF-12(12 Months)
- Return to Work(12 Months)
- Length of Hospital Stay(12 Months)
- VAS (Visual Analog Scale)(12 Months)
- Adverse Events(12 Months)
研究者
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