Identification of New Predictive Osseointegration Bio-Markers of the Prosthetic Implant in Patients With OsteoArthritis (BioPreIOA)
2021年7月30日 更新者:Istituto Ortopedico Rizzoli
The study involves the isolation and cellular, molecular and proteomic characterization of synoviocytes, osteoblasts and chondrocytes from tissue samples obtained from patients undergoing surgery of endo or arthroplasty for osteoarthritis (Experimental Group) or interventions for other causes such as for example periarticular fracture requiring the implantation of a prosthesis (Control Group)
研究概览
详细说明
The study involves the isolation and cellular, molecular and proteomic characterization of synoviocytes, osteoblasts and chondrocytes from tissue samples obtained from patients undergoing surgery of endo or arthroplasty for osteoarthritis (Experimental Group) or interventions for other causes such as for example periarticular fracture requiring the implantation of a prosthesis (Control Group) Deeper analysis of micro Ribo Nucleic Acid (RNA) and Non Coding RNA expressed by the synoviocytes, osteoblasts and chondrocytes will be performed in order to understand their possible involvement in pathways of osteogenic differentiation, through suitable experimental in vitro models of co-cultures.
In particular, investigators will focus on the cross-talk between synoviocytes and osteoblasts, cell populations involved in the post-surgical articular microenvironment and on which the osteointegration process of the joint prosthesis depends.
研究类型
观察性的
注册 (实际的)
9
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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BO
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Bologna、BO、意大利、40136
- IRCCS Istituto Ortopedico Rizzoli
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 及以上 (成人、年长者)
接受健康志愿者
不适用
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Male and female patients of age >40 years undergoing surgery of endo or arthroplasty for osteoarthritis or ifor other causes requiring the implantation of a prosthesis
描述
Inclusion Criteria:
- Male and Female patients > 40 years old hospitalized for surgery of endo- or arthroplasty for Osteoarthritis or for surgery for joint traumatic diseases (eg femoral neck fractures) requiring the implantation of a prosthesis
- Interval of at least three months from any previous infiltrative treatment of any kind;
- Patients able to provide written informed consent to the study.
Exclusion Criteria:
- Severe cognitive defects or psychiatric disorders;
- Tumor pathologies or concurrent antineoplastic therapies;
- Autoimmune diseases (rheumatoid arthritis);
- Surgery that involves the joint
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Osteoarthritis
Surgery for implantation of a prosthesis in case of Osteoarthritis
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Analysis of micro Ribo Nucleic Acid (RNA) expressed by the synoviocytes, osteoblasts and chondrocytes
其他名称:
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Non Osteoarthritis
Surgery for implantation of a prosthesis fon non Osteoarthritis cases
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Analysis of micro Ribo Nucleic Acid (RNA) expressed by the synoviocytes, osteoblasts and chondrocytes
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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miRNAs and LncRNA
大体时间:at the time of surgery (Day0)
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expression of miRNAs and LncRNA, from synoviocytes, osteoblasts and chondrocytes detected at the time of surgery
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at the time of surgery (Day0)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Biomarkers useful for predicting the efficiency of osseointegration of the implant
大体时间:at the time of surgery (Day0)
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the mRNAs and the identified proteins will be analyzed through the use of specific software, such as TargetScanPrediction.
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at the time of surgery (Day0)
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Validation of data obtained on miRNAs and lncRNAs
大体时间:at the time of surgery (Day0)
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Through in vitro co-culture systems, investigators will evaluate the role of previously identified miRNAs and lncRNAs in cross-talk between osteoblasts and synoviocytes isolated from patients with osteoarthritis.
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at the time of surgery (Day0)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅:Gianluca Giavaresi, MD、isituto ortopedico rizzoli
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Pelletier JP, Martel-Pelletier J, Abramson SB. Osteoarthritis, an inflammatory disease: potential implication for the selection of new therapeutic targets. Arthritis Rheum. 2001 Jun;44(6):1237-47. doi: 10.1002/1529-0131(200106)44:63.0.CO;2-F. No abstract available.
- Costa V, Raimondi L, Conigliaro A, Salamanna F, Carina V, De Luca A, Bellavia D, Alessandro R, Fini M, Giavaresi G. Hypoxia-inducible factor 1Alpha may regulate the commitment of mesenchymal stromal cells toward angio-osteogenesis by mirna-675-5P. Cytotherapy. 2017 Dec;19(12):1412-1425. doi: 10.1016/j.jcyt.2017.09.007. Epub 2017 Oct 27.
- Marijnissen AC, Lafeber FP. Re: E. B. Hunziker. Articular cartilage repair: basic science and clinical progress. A review of the current status and prospects. Osteoarthritis and Cartilage 2002; 10:432-63. Osteoarthritis Cartilage. 2003 Apr;11(4):300-1; author reply 302-4. doi: 10.1016/s1063-4584(02)00346-1. No abstract available.
- Zhang M, Lygrisse K, Wang J. Role of MicroRNA in Osteoarthritis. J Arthritis. 2017 Apr;6(2):239. doi: 10.4172/2167-7921.1000239. Epub 2017 Apr 28.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年12月14日
初级完成 (实际的)
2020年6月20日
研究完成 (实际的)
2020年6月20日
研究注册日期
首次提交
2018年9月27日
首先提交符合 QC 标准的
2018年10月29日
首次发布 (实际的)
2018年11月1日
研究记录更新
最后更新发布 (实际的)
2021年8月5日
上次提交的符合 QC 标准的更新
2021年7月30日
最后验证
2021年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.