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临床试验/NCT01366911
NCT01366911已完成不适用

Can Stem Cells Predict Orthopaedic Outcomes? The Correlation of Bone Density Findings Post Total Hip Arthoplasty With Stem Cell Assays Obtaned at Time of Surgery

University of Nebraska1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2011年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
203
试验地点
1
主要终点
Can Stem Cells Predict Orthopaedic Outcomes?

研究概览

简要总结

This is a pilot study to provide preliminary data of the association between bone mineral denity adjacent to acetabular implants, as measured by quanitative computed tomography (QCT), at least 2 years post Total Hip Arthoplasty (THA) surgery with Mesechymal stem cell assays, obtained at time of surgery, and to begin to evaluate if stem cells can predict orthopaedic surgical outcomes.

详细描述

Subjects who have undergone a THA and who previously consented to "Stem Cell Quality Assays: Correlation with Aging/Health" study which used excess bone marrow and blood samples to complete stem cell assay labs will be invited back at least 2 years post THA to complete bilateral hip x-rays, if not already completed as part of routine medical follow up plus a QCT bone density testing and to complete a questionnaire regarding smoking, alcohol and exercise history along with recording BMIs.

This ability to identify older individuals with compromised stem cell function could offer opportunities to develop and test new preventative and therapeutic strategies to improve outcomes.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • subjects who previously had a total hip arthroplasty and had stem cell assays completed on excess bone marrow

排除标准

  • Subjects who do not wish to participate.

结局指标

主要结局

Can Stem Cells Predict Orthopaedic Outcomes?

时间窗: Enrollment expected to begin June 2011and this pilot study is expected to be completed by May 2012.

Bone mineral density adjacent to acetabular implants will be evaluated using QCT which can show early bony changes, which can provide information about the quality of implant fixation and surrounding bone adaption. X-rays will evaluate component loosening, wear, alignmet and osteolytis. Patient characteristics will be summarized using descriptive statistics. Spearman correlation coefficients will be used to assess the association of Mesenchymal stem cell assays and bone density findings.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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