Glucose Metabolism Disorders and Metabolic Syndrome Before and After Primary Hip and Knee Replacement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Hyperglycemia in Joint Replacement Recipients: Glucose Metabolism Disorders and Metabolic Syndrome in Osteoarthritis Patients Before and After Primary Hip and Knee Replacement

Conditions
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Hyperglycemia, Hypercholesterolemia, Persistent Postoperative Pain, Hip Replacement, Knee Replacement

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary hip and knee replacement for osteoarthritis Enrolled previously into study NCT01021826 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hip and knee replacement recipients<br>Hip and knee replacement recipients (with osteoarthritis) enrolled previously into Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement study (NCT01021826). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glucose tolerance, measured using oral glucose tolerance test | The patients are grouped into three groups that are evaluated 12, 18 and ca. 24 months after surgery. | Baseline and 12-24 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cholesterol levels (HDL, LDL, triglycerides) |  | Baseline and 12-24 months after surgery | 
| Prolonged postoperative pain | Assessed using visual analog scale. Patients are divided in three groups that are evaluated 12, 18 and 24 months after surgery. | 12-24 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucose metabolism disorders, metabolic syndrome, joint replacement, osteoarthritis