NCT03503019Unknown不适用
Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study
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
- To examine the association between serum fructosamine levels and the risk for adverse outcomes (mainly PJI) following TJA among patients with and without diabetes.
- To compare the utility of fructosamine levels to HbA1c in predicting adverse outcomes.
- 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
- 否
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
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