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临床试验/NCT05877261
NCT05877261已完成不适用

5 Year Follow-Up of Migration of a Cementless Total Knee Replacement

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年5月25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
18
试验地点
1
主要终点
Implant Migration (tibial component)

研究概览

简要总结

All artificial joint implants need to be solidly held (fixed) within the bone. Cementless fixation has become a popular method to achieve fixation for total knee replacements where the bone grows directly onto the implanted device instead of using bone cement. The primary purpose of this study is to assess long-term implant survivorship and clinical outcomes of a previous study cohort that received a cementless knee replacement. As this study cohort approaches 5 years post-operation, the investigators will re-examine the stability of participant implants using specialized x-rays, called "radiostereometric analysis". The study will use weight-bearing computed tomography (CT) to measure bone density and texture features and correlate that with implant stability. The investigators will collect stool samples to assess participant gut microbiomes for biomarkers of poor bone quality that could correlate to implant stability. All 33 participants from the original study cohort will be invited to participate in this study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Were in the originally investigated cohort
  • Had successful imaging at 1-year post-operation
  • Minimum of 5 years post-operation

排除标准

  • Pregnancy
  • Unable to follow-up

结局指标

主要结局

Implant Migration (tibial component)

时间窗: 5 year follow-up

Implant movement will be measured with model-based Radiostereometric Analysis (RSA) by registering the location of the tibial component during supine exams. Potential tibial component migration between 1 and 5 years post-operation will be measured in millimeters with the use of tibial bone markers.

次要结局

  • Bone Density(5 year follow-up)
  • Implant Migration (femoral component)(5 year follow-up)
  • Inducible Displacement (RSA-based)(5 year follow-up)
  • Inducible Displacement (CT-based)(5 year follow-up)
  • Texture Features(5 year follow-up)
  • Microbial Diversity(5 year follow-up)

研究者

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

Brent Lanting

Orthopaedic Surgeon, Principal Investigator

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

研究点 (1)

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