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Glucose Metabolism Disorders and Metabolic Syndrome Before and After Primary Hip and Knee Replacement
HyTe-2
Hyperglycemia in Joint Replacement Recipients: Glucose Metabolism Disorders and Metabolic Syndrome in Osteoarthritis Patients Before and After Primary Hip and Knee Replacement
1 other identifier
observational
155
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 2, 2012
CompletedFirst Posted
Study publicly available on registry
December 6, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedOctober 18, 2023
October 1, 2023
4 months
December 2, 2012
October 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in cholesterol levels (HDL, LDL, triglycerides)
Baseline and 12-24 months after surgery
Prolonged postoperative pain
12-24 months after surgery
Other Outcomes (1)
Change in plasma adipokine and cytokine concentrations
Baseline and 12-24 months after surgery.
Study Arms (1)
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).
Eligibility Criteria
tertiary care clinic
You may qualify if:
- Primary hip and knee replacement for osteoarthritis
- Enrolled previously into study NCT01021826
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coxa, Hospital for Joint Replacementlead
- Tampere Universitycollaborator
- Tampere University Hospitalcollaborator
Study Sites (1)
Coxa, Hospital for Joint Replacement
Tampere, 33520, Finland
Related Publications (1)
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.
PMID: 25953426RESULT
Biospecimen
Plasma samples (one per patient).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Esa Jämsen, MD, PhD
Coxa, Hospital for Joint Replacement
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Researcher
Study Record Dates
First Submitted
December 2, 2012
First Posted
December 6, 2012
Study Start
April 1, 2012
Primary Completion
August 1, 2012
Study Completion
June 1, 2017
Last Updated
October 18, 2023
Record last verified: 2023-10