跳至主要内容
临床试验/NCT00843973
NCT00843973已完成不适用

Osteogenic Cell Viability in Bone Graft Obtained Using the Reamer Irrigator Aspirator (RIA) System Versus Iliac Crest Bone Graft

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
1
主要终点
Cell viability

研究概览

简要总结

The purpose of this study is to find out if the cells in bone graft samples collected using a reamer are similar to the cells in bone graft samples collected using the iliac crest bone graft method.

详细描述

Although iliac crest bone grafting is the gold standard for autogenous bone grafting procedures, limited quantity in some individuals and donor site morbidity have lead surgeons to look for alternative harvest sites or sources such as allograft or osteobiologics. Of these alternative harvest sites is the femoral shaft. Intramedullary contents from reaming are composed of bone marrow, and blood and bone spicules. In this respect, the reamed contents are similar to the bone routinely harvested from the iliac crest. Studies have shown that despite the reaming process using standard reamers, cells maintain their viability and are able to produce new bone. However, the addition of aspiration and irrigation used in the RIA system could potentially compromise the harvested cell viability and limit their osteogenic potential. In addition, Wenisch et al. have concluded that the harvested cells using standard intramedullary reamers not only proceed toward osteogenic differentiation, but also can be directed toward neurogenic differentiation. This suggests that reaming debris is a viable source of stem cells as well. RIA allows for these cells to be harvested. It is our hypothesis that the intramedullary contents harvested using the RIA system is similar to ICBG in cell viability and osteogenic potential.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects age 18 years or older
  • Subjects undergoing a bone grafting procedure, either using an iliac crest or RIA system harvesting technique, or
  • Subjects undergoing reamed femoral intramedullary nailing using the RIA reaming technique

排除标准

  • Subjects under age 18
  • Subjects with a history of: leukemia; cancer with bone metastases; renal failure, receiving dialysis; or on immunosuppressive medications

结局指标

主要结局

Cell viability

时间窗: 1 hour post-collection

Osteogenic potential

时间窗: 1 hour post-collection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brett Crist

Assistant Professor, Co-Director of Trauma Services, Co-Director Orthopaedic Trauma Fellowship, Department of Orthopaedic Surgery

University of Missouri-Columbia

研究点 (1)

Loading locations...

相似试验