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临床试验/NCT03503019
NCT03503019Unknown不适用

Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study

Rothman Institute Orthopaedics0 个研究点目标入组 3,000 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
3,000
主要终点
Prosthetic Joint Infection

研究概览

简要总结

A prospective multicenter study including all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and revision). Patients will be screened for glycemic control using HbA1c levels, fructosamine levels, and blood glucose levels. Blood samples will be obtained at the preadmission testing (PAT) within 30 days of surgery. On postoperative day 1 (POD-1), morning glucose levels will be obtained for all patients as well. Patients will be followed up for 90 days postop.

Study aims

  1. To examine the association between serum fructosamine levels and the risk for adverse outcomes (mainly PJI) following TJA among patients with and without diabetes.
  2. To compare the utility of fructosamine levels to HbA1c in predicting adverse outcomes.
  3. To determine the "best" threshold of fructosamine to determine adverse outcomes.

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

  • all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and revision)

排除标准

  • 未提供

结局指标

主要结局

Prosthetic Joint Infection

时间窗: within 90 days of surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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