NCT04960111Unknown不适用
Radiostereometry (Model Based RSA) in the Assessment of Knee Prosthesis Outcome:a Prospective,Pilot,Single-center Study.
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年12月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- micro-movement detection with radiostereometry and the patient's perception, measured with Short Form health survey12 at 12 month after surgery.
研究概览
简要总结
The innovative aspect of this research is the possibility of combining the data collected with radiostereometric model based Radiostereometry with the data collected through the Galeazzi Institute Registry.This opens the prospect of an earlier identification of patients undergoing prosthetic knee replacement with initial aseptic loosening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 是
入选标准
- •age more than 18
- •patients underwent total knee arthroplasty without controindications for this procedure
- •patients enrolled in PatientsReportedOutcomesMeasureS (PROMS) study
排除标准
- •age less than 18
- •comorbility that make difficult come back for follow-up
- •patients with allergy at materials used in Radiostereometry tecnique
- •infection
- •anemia, obesity, osteoporosis
- •pregnancy
结局指标
主要结局
micro-movement detection with radiostereometry and the patient's perception, measured with Short Form health survey12 at 12 month after surgery.
时间窗: 12 months
evaluate correlation between levels of micro-movement of the prosthetic components using radiostereometry model based RSA and the patient's perception, measured with Short Form health survey12 at 12 month after surgery.
次要结局
- correlation of micromovements and Patient reported outcomes at follow up(baseline to 24 months)
研究者
研究点 (2)
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