Glucose Metabolism Disorders and Metabolic Syndrome Before and After Primary Hip and Knee Replacement (HyTe-2)
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.
Persistent Postoperative Pain
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Hyperglycemia in Joint Replacement Recipients: Glucose Metabolism Disorders and Metabolic Syndrome in Osteoarthritis Patients Before and After Primary Hip and Knee Replacement|
- Change in glucose tolerance, measured using oral glucose tolerance test [ Time Frame: Baseline and 12-24 months after surgery ] [ Designated as safety issue: No ]The patients are grouped into three groups that are evaluated 12, 18 and ca. 24 months after surgery.
- Change in cholesterol levels (HDL, LDL, triglycerides) [ Time Frame: Baseline and 12-24 months after surgery ] [ Designated as safety issue: No ]
- Pain [ Time Frame: 12-24 months after surgery ] [ Designated as safety issue: No ]Assessed using visual analog scale. Patients are divided in three groups that are evaluated 12, 18 and 24 months after surgery.
- Change in plasma adipokine and cytokine concentrations [ Time Frame: Baseline and 12-24 months after surgery. ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Plasma samples (one per patient).
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||June 2016|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Hip and knee replacement recipients
Hip and knee replacement recipients (with osteoarthritis) enrolled previously into "Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement" study (NCT01021826).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743313
|Coxa, Hospital for Joint Replacement|
|Tampere, Finland, 33520|
|Study Director:||Esa Jämsen, MD, PhD||Coxa, Hospital for Joint Replacement|