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临床试验/NCT03830931
NCT03830931已完成不适用

Hyperglycemia in Knee Arthroplasty Surgery

Lund University1 个研究点 分布在 1 个国家目标入组 1,448 人开始时间: 2019年1月1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
1,448
试验地点
1
主要终点
The presence of postoperative hyperglycemia after primary knee arthroplasty surgery

研究概览

简要总结

Patients in three hospitals in Sweden who will have knee arthroplasty surgery for the first time are invited to participate in the study, approximately 2000 patients. The fasting glucose value (fP-glucose) is obtained via a blood sample the day after the knee arthroplasty surgery. The sample is analyzed and the glucose value obtained is documented and sent to the Swedish Knee Arthroplasty Register (SKAR). In the SKAR there is information on patient characteristics, diagnosis, prosthesis, anesthetic form and primary and secondary operations, etc. The unique personal numbers of the included patients are submitted to the National Board of Health and Welfare, which matches the cohort with the Patient Register to identify adverse events, re-admission and death in a year after the surgery. SKAR has carried out several interactions with the National Board of Health and Welfare, and possesses clinical expertise as well as registers and biostatistics expertise. Incidence calculation of the proportion that develops elevated glucose levels after surgery and Cox regression for group comparison (elevated glucose vs. non-elevated) taking into account factors within groups such as age, gender, etc. This is a register-based observation study. Since the incidence of elevated glucose value after a knee prosthesis operation is not known, we are planning for a representative selection from three major prosthetic clinics in Sweden. Regarding the secondary purposes, our ability to answer these depends on the presence of elevated glucose levels. The inclusion start in January 2019 and lasts for one year. Incidence calculations can be made as soon as all patients are included, but 90-day data from the patient register can reasonably be completed

详细描述

Purpose

To reduce the risk of prosthetic joint infection (PJI) after primary knee arthroplasty surgery.

The aims are to study:

  • the presence of postoperative hyperglycemia after knee arthroplasty.
  • if there is an increased risk of wound disturbance
  • if there is an increased risk of PJI.
  • if there is an increased risk of other complications, re-admissions and mortality.
  • if postoperative hyperglycemia is more common after general than spinal anesthesia.
  • if patients developing hyperglycemia has longer hospital stay.

Background

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients operated on with a primary knee arthroplasty in 3 hospitals in Sweden.
  • Approved to participate in the study.

排除标准

  • Not approved to participate in the study.

结局指标

主要结局

The presence of postoperative hyperglycemia after primary knee arthroplasty surgery

时间窗: The postoperative fP-Glucose will be assessed 1 day after primary knee arthroplasty surgery

fP-Glucose

次要结局

  • The presence of adverse events after primary knee arthroplasty surgery(90-days after primary knee arthroplasty surgery)
  • The presence of prosthetic joint infection (PJI) after primary knee arhroplasty surgery(within 1 year after primary knee arthroplasty surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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