A Randomized, Controlled Study to Evaluate Effectiveness of AlloWrap® Amniotic Membrane for the Reduction of Post-Operative Soft Tissue Inflammation in Two-Level Anterior Cervical Discectomy and Fusion Procedures
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- AlloSource
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Swelling Index 1 Month
研究概览
简要总结
The primary objective of this study is to obtain evidence of the effectiveness of AlloWrap Amniotic Membrane in the reduction of soft tissue swelling in two-level ACDF procedures.
详细描述
AlloWrap® is a dual sided human amniotic membrane, procured from consented human tissue donors who elect to have scheduled cesarean births. A Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) as defined by the United States Food and Drug Administration (FDA) 21 CFR Part 1271, AlloWrap® is intended to provide a biologic barrier following surgical repair. Designed to meet the clinical needs of the patient and practical needs of the clinical setting amniotic based surgical barriers have been shown to contain a natural balance of cytokines that can assist the body in reducing epidural fibrosis, inflammation, and infection at the surgical site. Using AlloWrap® as a surgical barrier may result in outcomes with less scaring, potentially reducing pain and assisting the patient in returning to normal functionality while potentially making revision dissections less complicated. The purpose of this clinical study is to evaluate the use of AlloWrap® Amniotic Membrane in ACDF procedures to obtain evidence of effectiveness, defined as the reduction, and the possible prevention, of complications associated with ACDF surgery such as odynophagia and/or dysphasia that result from soft tissue inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be a skeletally mature male or a non-pregnant, non-lactating female ≥18 years of age;
- •Radiographically diagnosed with cervical stenosis or cervical disc disorder and/or degeneration, spondylolisthesis and/or cervical radiculopathy resulting from neural element compression as confirmed by MRI, CT, CT myelogram;
- •Neurological dysfunction or radicular symptoms by history and physical exam;
- •Is scheduled/or will be scheduled to undergo an anterior cervical fusion, requiring internal fixation using an anterior cervical standalone interbody cage system;
- •Failed to gain adequate relief from non-operative treatment, including but not limited to medications, physical therapy, chiropractic care, home exercise and/or for at least 6 weeks; or the patient has progressive muscle weakness or atrophy or intractable pain;
- •Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
排除标准
- •Have a documented medical history or radiographic evidence of osteoporosis or other condition which would negatively impact the bone healing process (e.g. history of Paget's disease, osteomalacia, or other osteodystrophy) or preclude the subject from receiving screw fixation;
- •Have had or plans to have an epidural steroid injection or has taken NSAIDs ≤ 7 days prior to surgery;
- •Circulatory, cardiac, or pulmonary problems that could cause excessive surgical risk based on the opinion of the Investigator;
- •Active malignancy; Nondiscogenic source of symptoms (e.g., tumor, etc.) or undergoing treatment for tumor or boney traumatic injury to the cervical spine or a history of any invasive malignancy (except non-melanoma skin cancer), unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
- •Acute cervical trauma ≤ 6 months prior to surgery;
- •Inflammatory disease of the cervical spine;
- •Has a history of substance abuse (recreational drugs, alcohol) that has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an in-patient substance abuse program;
- •Is currently involved in a study of another investigational product for similar purpose or has been in the previous 90 days;
- •Active infection at the operative level, or a systemic infection including prior or pending treatment for HIV, Hepatitis B or Hepatitis C;
- •Mentally compromised (e.g., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to participate in the clinical study;
- •Currently immunologically suppressed or immunocompromised, or a medical condition requiring radiation, chemotherapy or immunosuppression;
- •Subjects who, in the opinion of the Investigator, would not be able or willing to comply with the protocol;
- •Have a history of any autoimmune disease, such as, systemic lupus erythematosus (SLE), Addison's disease, Crohn's disease, multiple sclerosis or rheumatoid arthritis;
- •Has had prior cervical spine surgery;
- •Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer or uncontrolled diabetes;
- •Have symptomatic disease requiring fusion of one level or > 2 levels and/or requiring fusion between levels C2-C4;
- •Has cervical deformity secondary to acute or chronic traumatic fracture or neoplasm, including vertebral, facet or posterior element fracture or dislocation;
- •Requires a concomitant posterior cervical surgery at the time of the ACDF;
- •Has any contraindications for MRI;
- •Is a ward of the state, prisoner, or transient.
结局指标
主要结局
Swelling Index 1 Month
时间窗: 1 month
Difference of change from baseline to 1 month post operatively of soft tissue thickness/swelling, as measured by the swelling index on lateral x-rays.
次要结局
- Neck Disability Index (NDI) Scores(1, 3, 6 and 12 months)
- Air Index Scores(1, 3, 6 and 12 months)
- Visual Analog Scale (VAS) Scores(1, 3, 6 and 12 months)
- Swallowing Quality of Life Questionnaire (SWAL-QOL) Scores(1, 3, 6 and 12 months)
- Swelling Index Other Timepoints(3, 6 and 12 months)
- Revision Surgery(1, 3, 6 and 12 months)