Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF): Evaluation of Radiographic and Patient Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 17
- 主要终点
- To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ACDF subjects.
研究概览
简要总结
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).
详细描述
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ACDF subjects.
时间窗: from pre-op to 24-month follow-up
次要结局
- To evaluate the rate of complications for Osteocel Plus and compare to published and/or retrospective data for autograft or bone morphogenetic protein (BMP).(from pre-op to 24-month follow-up)
- To evaluate and compare each outcome with respect to surgical time and blood loss.(from pre-op to 24-month follow-up)
- To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain).(from pre-op to 24-month post-op)