跳至主要内容
临床试验/NCT03726918
NCT03726918已完成不适用

Identification of New Predictive Osseointegration Bio-Markers of the Prosthetic Implant in Patients With OsteoArthritis

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2018年12月14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
9
试验地点
1
主要终点
miRNAs and LncRNA

研究概览

简要总结

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)

详细描述

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Severe cognitive defects or psychiatric disorders;
  • Tumor pathologies or concurrent antineoplastic therapies;
  • Autoimmune diseases (rheumatoid arthritis);
  • Surgery that involves the joint

结局指标

主要结局

miRNAs and LncRNA

时间窗: at the time of surgery (Day0)

expression of miRNAs and LncRNA, from synoviocytes, osteoblasts and chondrocytes detected at the time of surgery

次要结局

  • Biomarkers useful for predicting the efficiency of osseointegration of the implant(at the time of surgery (Day0))
  • Validation of data obtained on miRNAs and lncRNAs(at the time of surgery (Day0))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Identification of New Predictive Osseointegration... | 临床试验