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临床试验/NCT04953702
NCT04953702招募中不适用

Insufficiency Fractures of the Knee: Insufficient of Nutrients or Cartilage?

Tomer Korabelnikov1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Correlation between subchondral insufficiency fractures (SIFKs) and coexisting conditions

研究概览

简要总结

This prospective cohort study is designed to investigate possible association(s) between subchondral insufficiency fractures (SIFKs) of the knee and pre-existing health, lifestyle, and/or musculoskeletal conditions. In doing so, this research may shed light on the underlying cause(s) of SIFKs. It is hypothesized that SIFKs of the knee are related to osteoarthritis, weak bone, and/or metabolic issues, rather than trauma.

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

入选标准

  • Patients diagnosed with SIFK from ages ≥18 years old who seek treatment at the University of Massachusetts for their musculoskeletal care.

排除标准

  • Patients with a history of associated conditions such as cancer, inflammatory arthritis, or chronic alcohol or tobacco dependence will be excluded.
  • The following special populations will be excluded:
  • Adults unable to consent and/or unable to follow two-step commands
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
  • Non-English-speaking patients

结局指标

主要结局

Correlation between subchondral insufficiency fractures (SIFKs) and coexisting conditions

时间窗: 12 months

The proportion of patients with subchondral insufficiency fractures and coexisting conditions (overall and per condition) as compared to those without coexisting conditions. Coexisting conditions are identified and defined through metabolic and musculoskeletal-related findings from available lab and radiological results in the patient medical record, such as those related to diabetes, obesity, osteoarthritis and other orthopedic related conditions and metabolic issues.

次要结局

  • Correlation between type of treatment for subchondral insufficiency fractures (SIFKs) and treatment outcome (pain level)(12 months)
  • Correlation between activity level and treatment outcome (pain level)(12 months)
  • Correlation between coexisting conditions and treatment outcome (pain level)(12 months)

研究者

发起方
Tomer Korabelnikov
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tomer Korabelnikov

Principal Investigator

University of Massachusetts, Worcester

研究点 (1)

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