NCT01357187已完成不适用
An Evaluation of the Effect of the AmnioFix™ Amniotic Membrane Allograft on Scar Tissue and Adhesions in Patients Undergoing Posterior Instrumentation Removal
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Tenacity and frequency of soft tissue adhesion
研究概览
简要总结
The objective of this study is to evaluate the clinical effectiveness of AmnioFix™ in the reduction of the tenacity and frequency of soft tissue adhesions during the removal of segmental posterior lumbar instrumentation.
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
- •Adults (18 years or older)
- •Diagnosed with lumbar pathology requiring elective lumbar interbody fusion
- •Willingness to comply to follow-up examinations and diagnostic imaging procedures
- •Ability to give full written informed consent
排除标准
- •Previous surgical procedure performed at same site
- •Sign or symptoms of other disease which could result in allograft failure
- •Require a corpectomy
- •Participating in another drug or device clinical trial
- •Pregnant or may become pregnant during the study
- •Involved in workmen's compensation or other litigation relative to a spine injury
- •Past medical history of allograft implantation which resulted in graft failure
- •Any condition requiring treatment above the normal standard of care
- •Currently taking medications which could affect graft incorporation (supervising physicians discretion)
- •Auto-Immune disease
- •Renal failure
- •Failure to sign or understand informed consent information
- •History of drug and/or alcohol abuse
- •Allergic to aminoglycosides
结局指标
主要结局
Tenacity and frequency of soft tissue adhesion
时间窗: At the time of removal of segmental posterior lumbar instrumentation
次要结局
- Presence and extent of scar tissue using histological analysis of the lumbar tissue adjacent to the surgical site(At the time of removal of segmental posterior lumbar instrumentation)
- Number of intra-operative complications(At the time of removal of segmental posterior lumbar instrumentation)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar FasciitisPlantar FasciitisNCT01659827MiMedx Group, Inc.45
已完成
不适用
Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot UlcersDiabetic Foot UlcerNCT01657474MiMedx Group, Inc.40
已完成
不适用
Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic ProstatectomyPudendal NerveNCT01832168MiMedx Group, Inc.34
已完成
不适用
Human Amniotic Membrane Grafting and Standard of Care Versus Standard of Care Alone in the Treatment of Venous Leg UlcersVenous Leg UlcerNCT01552447MiMedx Group, Inc.98
已完成
不适用
Amniotic Membrane for Donor Site HealingBurnsNCT02947737Emory University4