Hyperglycemia in Joint Replacement Recipients: Glucose Metabolism Disorders and Metabolic Syndrome in Osteoarthritis Patients Before and After Primary Hip and Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Change in glucose tolerance, measured using oral glucose tolerance test
研究概览
简要总结
Osteoarthritis patients undergoing primary hip and knee replacement are followed-up and changes in their glucose metabolism and other metabolic parameters (obesity, cholesterol levels) are examined. Persistent postoperative pain is examined as secondary outcome.
详细描述
Glucose metabolism disorders (diabetes and pre-diabetes) and metabolic syndrome are common in joint replacement recipients. Improved physical activity following joint replacement could lead to better glucose control in diabetes and ameliorate impaired glucose and cholesterol levels. In this study patients previously recruited to "Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement" study are being followed-up for one year in order to analyze if joint replacements have an effect on these metabolic abnormalities. In addition, the effect of glucose metabolism disorders on occurrence of persistent pain after surgery is analyzed.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary hip and knee replacement for osteoarthritis
- •Enrolled previously into study NCT01021826
排除标准
- •Arthritis other than osteoarthritis (based on study NCT01021826)
- •Medication affecting glucose metabolism (excl. antidiabetic agents) (based on study NTC01021826)
- •Died before follow-up phase
- •Did not undergo the planned hip or knee replacement
结局指标
主要结局
Change in glucose tolerance, measured using oral glucose tolerance test
时间窗: Baseline and 12-24 months after surgery
The patients are grouped into three groups that are evaluated 12, 18 and ca. 24 months after surgery.
次要结局
- Change in cholesterol levels (HDL, LDL, triglycerides)(Baseline and 12-24 months after surgery)
- Prolonged postoperative pain(12-24 months after surgery)
研究者
Esa Jamsen
MD, PhD, Researcher
Coxa, Hospital for Joint Replacement