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

Terminated

• Conditions: Hip Replacement; Persistent Postoperative Pain; Hypercholesterolemia; Knee Replacement; Hyperglycemia

• Registration Number: NCT01743313
• Lead Sponsor: Coxa, Hospital for Joint Replacement

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-08
• Study First Submitted: 2012-12-02
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Study Completion: 2017-06
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 155

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in glucose tolerance, measured using oral glucose tolerance test	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Coxa, Hospital for Joint Replacement; 🇫🇮 Tampere, Finland