Clinical trial NCT01743313: Glucose Metabolism Disorders and Metabolic Syndrome Before and After Primary Hip and Knee Replacement
Official title: Hyperglycemia in Joint Replacement Recipients: Glucose Metabolism Disorders and Metabolic Syndrome in Osteoarthritis Patients Before and After Primary Hip and Knee Replacement
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hyperglycemia
Hypercholesterolemia
Persistent Postoperative Pain
Hip Replacement
Knee Replacement
Keywords: glucose metabolism disorders
metabolic syndrome
joint replacement
osteoarthritis
Lead sponsor: Coxa, Hospital for Joint Replacement
Sponsor class: OTHER
Collaborators: name: Tampere University
name: Tampere University Hospital
First posted: 2012-12-06
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary care clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in glucose tolerance, measured using oral glucose tolerance test
timeFrame: Baseline and 12-24 months after surgery
Secondary outcomes:
measure: Change in cholesterol levels (HDL, LDL, triglycerides)
timeFrame: Baseline and 12-24 months after surgery
measure: Prolonged postoperative pain
timeFrame: 12-24 months after surgery
Other outcomes:
measure: Change in plasma adipokine and cytokine concentrations
timeFrame: Baseline and 12-24 months after surgery.
Locations:
city: Tampere
country: Finland
facility: Coxa, Hospital for Joint Replacement
Study officials:
affiliation: Coxa, Hospital for Joint Replacement
name: Esa Jämsen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Rajamaki TJ, Jamsen E, Puolakka PA, Nevalainen PI, Moilanen T. Diabetes is associated with persistent pain after hip and knee replacement. Acta Orthop. 2015;86(5):586-93. doi: 10.3109/17453674.2015.1044389.