This trial is active, not recruiting.

Conditions hyperglycemia, hypercholesterolemia, persistent postoperative pain, hip replacement, knee replacement
Sponsor Coxa, Hospital for Joint Replacement
Collaborator University of Tampere
Start date April 2012
End date August 2012
Trial size 155 participants
Trial identifier NCT01743313, 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Hip and knee replacement recipients (with osteoarthritis) enrolled previously into "Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement" study (NCT01021826).

Primary Outcomes

Change in glucose tolerance, measured using oral glucose tolerance test
time frame: Baseline and 12-24 months after surgery

Secondary Outcomes

Change in cholesterol levels (HDL, LDL, triglycerides)
time frame: Baseline and 12-24 months after surgery
time frame: 12-24 months after surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Hyperglycemia in Joint Replacement Recipients: Glucose Metabolism Disorders and Metabolic Syndrome in Osteoarthritis Patients Before and After Primary Hip and Knee Replacement
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Coxa, Hospital for Joint Replacement.