Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF)
2014年1月7日 更新者:NuVasive
Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF): Evaluation of Radiographic and Patient Outcomes
This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive ACDF surgery at one or two levels.
These subjects will present with degenerative conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment.
Subjects will receive Osteocel Plus, without any other biologic product, during their ACDF operation.
The ACDF procedure will be conducted with a radiolucent graft containment device such that progression of fusion can be adequately assessed via radiograph.
Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion.
This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and Bone Morphogenetic Protein (BMP).
研究概览
详细说明
A total of 175 subjects will be selected for enrollment in this study from multiple centers.
The subjects will have degenerative conditions in the cervical spine and will be undergoing ACDF surgery as treatment at one or two levels.
The following eligibility criteria are designed to select subjects for whom protocol treatment is considered appropriate.
All relevant medical and non-medical conditions should be taken into consideration when deciding whether this protocol is suitable for a particular subject.
研究类型
观察性的
注册 (实际的)
182
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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California
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La Jolla、California、美国、92037
- Shiley Center for Orthopaedic, Scripps Green Hospital
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Redwood City、California、美国、94063
- Stanford University
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San Diego、California、美国、92103
- UCSD Department of Orthpaedic Surgery, UCSD Medical Center
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Santa Monica、California、美国、90404
- The Spine Institute, St. John's Health Center
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Florida
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Tampa、Florida、美国、33606
- University of South Florida Department of Neurosurgery, Tampa General Hospital
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Georgia
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Marietta、Georgia、美国、30060
- Pinnacle Orthopaedics, Wellstone Kennestone Hospital
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Illinois
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Joliet、Illinois、美国、60435
- Hinsdale Orthopaedic Associates, Provena Saint Joseph Medical Center
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Indiana
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Indianopolis、Indiana、美国、46219
- Indiana Center for NeuroSurgery, Indiana Surgery Center East
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Missouri
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Columbia、Missouri、美国、65201
- Columbia Orthopaedic Group, Boone Hospital Center
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Montana
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Billings、Montana、美国、59101
- NWREI (for Ortho Montana)
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New York
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Lockport、New York、美国、14094
- Buffalo Spine Surgery, Kenmore Mercy
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North Carolina
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Durham、North Carolina、美国、27708
- Duke University Medical Center
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Ohio
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Chillicothe、Ohio、美国、45601
- The Center for Advanced Orthopaedics, Adena Bone and Joint Center
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19106
- University of Pennsylvania
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Texas
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Southlake、Texas、美国、76092
- Spine Team Texas, Texas Health Harris Methodist Hospital Southlake
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Virginia
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Winchester、Virginia、美国、22601
- Winchester Medical Center
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Washington
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Seattle、Washington、美国、98122
- Swedish Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Existing clinic patients
描述
Inclusion Criteria:
- Persistent neck and/or arm pain unresponsive to conservative treatment for at least 6 weeks, unless clinically indicated sooner
- Indicated for anterior fusion at one or two contiguous cervical levels (C3 to T1)
- Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
- 18-70 years of age at the date of written informed consent
- Able to undergo surgery based on physical exam, medical history and surgeon judgment
- Expected to survive at least 2 years beyond surgery
- Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
- Signed and dated Informed Consent Form
Exclusion Criteria:
- Patient has a mental or physical condition that would limit the ability to comply with study requirements
- Cervical spine abnormality requiring treatment at more than two levels
- Systemic or local infection; active or latent
- Previous failed fusion at the operative level
- Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
- Undergoing chemotherapy or radiation treatment, or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
- Pregnant, or plans to become pregnant during the study
- Subject is a prisoner
- Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended)
- A significant general illness (e.g., HIV, active metastatic cancer of any type) is present; subject is immunocompromised or is being treated with immunosuppressive agents that decrease the probability of survival to the two-year endpoint of the study
- Participating in another clinical study at any time during the study participation that would confound study data
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ACDF subjects.
大体时间:from pre-op to 24-month follow-up
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from pre-op to 24-month follow-up
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次要结果测量
结果测量 |
大体时间 |
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评估 Osteocel Plus 的并发症发生率,并与自体移植或骨形态发生蛋白 (BMP) 的已发表和/或回顾性数据进行比较。
大体时间:从术前到 24 个月的随访
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从术前到 24 个月的随访
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评估和比较每个结果的手术时间和失血量。
大体时间:从术前到 24 个月的随访
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从术前到 24 个月的随访
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To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain).
大体时间:from pre-op to 24-month post-op
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from pre-op to 24-month post-op
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任:Kelli Howell, MS、NuVasive
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年2月1日
初级完成 (实际的)
2012年10月1日
研究完成 (实际的)
2012年10月1日
研究注册日期
首次提交
2009年7月16日
首先提交符合 QC 标准的
2009年7月17日
首次发布 (估计)
2009年7月20日
研究记录更新
最后更新发布 (估计)
2014年1月8日
上次提交的符合 QC 标准的更新
2014年1月7日
最后验证
2014年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Biologic - Osteocel Plus的临床试验
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InBios International, Inc.Biomedical Advanced Research and Development Authority; Fast-Track Drugs & Biologics, LLC完全的
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Azienda Sanitaria Locale Napoli 2 Nord招聘中
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Zona Health, IncResearch & Development Concierge Company终止
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Fondazione Policlinico Universitario Agostino Gemelli...尚未招聘尿路感染 | 输尿管支架相关症状